The complete schedule for the three posters being presented at the APS meeting follows:

• Thursday, May 9, 9:30-11:00 a.m., Poster 407“Long-term efficacy and safety of opioid therapy for chronic non-cancer pain: evidence from randomized and open-label studies.”
  R. Matsuno, L. Wallace, R. Glanzman, B. Martell, P. Coplan
• Thursday, May 9, 9:30-11:00 a.m., Poster 399“Duration of use of extended-release oxycodone and morphine among adults with cancer and non-cancer pain.”
  A. DeVeaugh-Geiss, H. Chilcoat, P. Coplan
• Friday, May 10, 9:30-11:00 a.m., Poster 408“What’s the difference? Within-patient versus between-patient designs to evaluate the effects of long-term opioid therapy.”
  R. Matsuno, L. Wallace, R. Glanzman, B. Martell, P. Coplan

The first poster, “Long-term efficacy and safety of opioid therapy for chronic non-cancer pain: evidence from randomized and open-label studies analyzed data from two randomized clinical trials and 40 open-label extension trials, most of which were six months or longer. The data describes the long-term safety and efficacy of opioid analgesic therapy for chronic non-cancer pain.

The second poster, “Duration of use of extended-release oxycodone and morphine among adults with cancer and non-cancer pain,” used data from a national insurance database and assessed the duration of use of extended-release morphine vs. extended-release (ER) oxycodone among cancer and non-cancer patients. Overall, most patients dispensed a new ER oxycodone or ER morphine prescription had a non-malignant pain condition. Fewer than one in five of these patients received continuous treatment for more than six months.

The third poster is titled, “What’s the difference? Within-patient versus between-patient designs to evaluate the effects of long-term opioid therapy.” Purdue conducted a literature search of observational studies evaluating LTO therapy including both within patient (single-arm open-label trials and open-label extensions-to-RCTs) and between-patient (cross-sectional and cohort studies) designs and compared their results regarding efficacy, safety, and function/quality of life. Any apparent value of LTO therapy may be influenced by the type of observational studies referenced.

“Purdue recognizes the importance of proper patient selection and monitoring when considering how, when and to whom opioid pain medications should be prescribed,” said Gary L. Stiles, M.D., vice president of research and development at Purdue. “It is important to take into account the diversity, duration, and impact of pain on the patient, as well as the potential for misuse, abuse and addiction. There is no “one-size-fits-all” approach to treating a diverse patient population.”

The authors of these posters are all full-time employees of Purdue Pharma L.P. and the reviews were funded by the Company.

# # #

About Purdue Pharma L.P.
Purdue Pharma L.P. and its associated U.S. companies are privately held pharmaceutical companies known for pioneering research on persistent pain. Headquartered in Stamford, CT, Purdue Pharma is engaged in the research, development, production and distribution of both prescription and over-the-counter medicines and hospital products. Additional information about Purdue can be found at www.purduepharma.com.

Contact:
Libby Holman
Associate Director
Public Affairs
Tel: 203-588-7670
Cell: 203-609-1291
Email: libby.holman@pharma.com

Stamford, CT – April 26, 2013 – Purdue Pharma L.P. and Actavis, Inc. announced today that the companies have agreed to resolve the patent infringement lawsuits between them now pending in the United States District Court for the Southern District of New York concerning certain Purdue patents, including patents for abuse-deterrent technology, protecting OxyContin® (oxycodone HCl controlled-release) Tablets CII (“OxyContin”). According to the agreement, Actavis will acknowledge the validity and enforceability of Purdue’s patents and that their generic formulation of OxyContin infringed those patents. In exchange, Purdue will grant a license to Actavis to sell defined quantities of either a generic version or an authorized generic version of reformulated OxyContin tablets starting as early as 2014.

“Today’s agreement will promote competition and allow for availability of generic formulations of reformulated OxyContin. At the same time, this resolution relieves us of the risks, distractions and costs of continued litigation. We are pleased that this matter has been resolved in a manner that respects the inventions we have incorporated into the reformulated OxyContin tablets,” said John H. Stewart, president and CEO of Purdue. “Our dedication to serving both healthcare professionals and patients with innovative prescription and non-prescription products has never waned and we look forward to maintaining that commitment.”

The professional product labeling for OxyContin® Tablets contains the following Boxed Warning:

Indications and Usage
OxyContin is indicated for the management of moderate to severe pain when a continuous, around-the-clock opioid analgesic is needed for an extended period of time.

Limitations of Use
OxyContin is not for use:

• As an as-needed (prn) analgesic
• For pain that is mild or not expected to persist for an extended period of time
• For acute pain
• In the immediate postoperative period
• For postoperative pain, unless the patient is already receiving chronic opioid therapy prior to surgery, or if the postoperative pain is expected to be moderate to severe and persist for an extended period of time

OxyContin 60 mg and 80 mg tablets, a single dose greater than 40 mg, or a total daily dose greater than 80 mg are only for patients in whom tolerance to an opioid of comparable potency is established. Patients considered opioid tolerant are those who are taking at least 60 mg oral morphine/day, 25 mcg transdermal fentanyl/hour, 30 mg oral oxycodone/day, 8 mg oral hydromorphone/day, 25 mg oral oxymorphone/day, or an equianalgesic dose of another opioid for one week or longer.

Contraindications
OxyContin is contraindicated in patients with:

• Significant respiratory depression
• Acute or severe bronchial asthma in an unmonitored setting or in the absence of resuscitative equipment
• Known or suspected paralytic ileus and gastrointestinal obstruction
• Hypersensitivity (e.g., anaphylaxis) to oxycodone

Additional Safety Information
Respiratory depression is the chief hazard of opioid agonists, including OxyContin. Respiratory depression is more likely to occur in elderly, cachectic, and debilitated patients, and patients with chronic pulmonary disease; therefore closely monitor these patients.

Hypotension, and profound sedation, coma or respiratory depression may result if OxyContin is used concomitantly with other CNS depressants (e.g., sedatives, anxiolytics, hypnotics, neuroleptics, muscle relaxants, other opioids). When considering the use of OxyContin in a patient taking a CNS depressant, assess the duration of use of the CNS depressant and the patient’s response, including the degree of tolerance that has developed to CNS depression. If OxyContin therapy is to be initiated in a patient taking a CNS depressant, start with a lower OxyContin dose than usual and monitor patients for signs of sedation and respiratory depression and consider using a lower dose of the concomitant CNS depressant.

Use caution when prescribing OxyContin for patients who have difficulty swallowing or have underlying GI disorders that may predispose them to obstruction. Instruct patients not to pre-soak, lick or otherwise wet OxyContin Tablets prior to placing in the mouth, and to take one tablet at a time with enough water to ensure complete swallowing immediately after placing in the mouth.

OxyContin may increase the risk of serious adverse reactions such as those observed with other opioid analgesics, including respiratory depression, apnea, respiratory arrest, circulatory depression, hypotension, or shock. The most common adverse reactions (>5%) reported by patients in clinical trials comparing OxyContin with placebo are: constipation, nausea, somnolence, dizziness, vomiting, pruritus, headache, dry mouth, asthenia, and sweating.

Full prescribing information for OxyContin® is available at www.purduepharma.com/OxyContinPI.

Purdue Pharma L.P. and its associated U.S. companies are privately-held pharmaceutical companies known for pioneering research on persistent pain. Headquartered in Stamford, CT, Purdue is engaged in the research, development, production, and distribution of both prescription and over-the-counter medicines and hospital products. Additional information about Purdue can be found at www.purduepharma.com.

# # #

Contact:

Libby Holman
Associate Director
Public Affairs
Tel: 203-588-7670
Cell: 203-609-1291
Email: libby.holman@pharma.com

James Heins
Senior Director
Public Affairs
Tel: 203-588-8069
Cell: 203-856-2121
Email: james.heins@pharma.com

April 16, 2013 – STAMFORD, Conn. – Purdue Pharma L.P. today announced that the U.S. Food and Drug Administration (FDA) has approved new language for the product label for OxyContin^® (oxycodone hydrochloride controlled-release) Tablets CII that describes abuse-deterrence studies conducted with the reformulated tablets. Additionally, Purdue is gratified that the FDA has determined that the original OxyContin extended release tablets were withdrawn from sale for reasons of safety or effectiveness. FDA will not accept or approve any abbreviated new drug applications (generics) that rely upon the approval of original OxyContin.

The new labeling information is reflected in the product label’s Section 9.2 titled Abuse. The updates include:

• Change of language in the subsection titled Risks Specific to Abuse of OxyContin
• Addition of a new subsection entitled Abuse Deterrence Studies, which includes:
  • In Vitro Testing Description
  • Clinical Studies Descriptions featuring a Table and Figure
    • Table 2: Summary of Maximum Drug Liking (Emax) Data Following Intranasal Administration
    • Figure 1: Percent Reduction Profiles for Emax of Drug Liking VAS for OxyContin vs. oxycodone HCl, N=27 Following Intranasal Administration
  • Inclusion of a Summary of the study results

Full prescribing information for OxyContin® is available at www.PurduePharma.com/OxyContinPI. Also, read the boxed warning and additional safety information below.

“Purdue Pharma is pleased with the FDA’s approval of this new language for the OxyContin label, which will provide important information to healthcare professionals,” said Gary L. Stiles, MD, Senior Vice President of Research and Development at Purdue Pharma L.P. “While the data from the abuse-deterrence studies have been included in the product label, OxyContin remains a Schedule II controlled substance and healthcare professionals should continue to exercise care in selecting and monitoring patients when prescribing OxyContin.”

“Prescriber and patient education remains critically important to ensuring the proper use of opioid analgesics,” said Dr. Stiles. “We strongly encourage prescribers to take advantage of the professional education resources developed as part of the Risk Evaluation and Mitigation Strategy (REMS) for extended-release and long-acting opioids.”

In August of 2010, Purdue introduced the reformulated version of OxyContin in an effort to make the tablet more difficult to manipulate for the purpose of misuse and abuse by various routes of administration, e.g., snorting and intravenous (iv) injection. The reformulated tablet has properties intended to prevent it from being easily cut, broken, crushed or dissolved to release more medication. The physical and chemical properties of the reformulated tablet would not, however, be expected to have any impact on misuse or abuse by persons who swallow intact tablets in doses larger than are recommended or without legitimate purpose. Even intact tablets can lead to overdose and death when abused, as they are designed to release the medicine when swallowed.

Purdue has completed laboratory manipulation and extraction testing, pharmacokinetic and abuse “liking” studies for the reformulation of OxyContin. Additionally, Purdue has undertaken a series of epidemiological studies to evaluate in real world settings whether the changes made to OxyContin’s formulation are resulting in a decrease in misuse and abuse and their consequences: addiction, overdose and death. Results from these studies are being reported to the FDA on an ongoing basis and have also been presented at scientific meetings and/or published in peer-reviewed medical journals.

Purdue recognizes that abuse of prescription opioid analgesics is a persistent and significant public health problem. In addition to the risks abusers face, their actions also threaten access to these medicines by patients with legitimate medical need. For these reasons, Purdue is working to incorporate abuse-deterrence technologies into its portfolio of oral, solid-dosage form opioid analgesic products. Amongst multiple ongoing development projects intended to provide abuse deterrence are additional formulations of oxycodone, morphine and a once-daily formulation of hydrocodone bitartrate, which is in the final stages of clinical development and incorporates the same abuse-deterrence technology as reformulated OxyContin.

Developing abuse-deterrence formulations is just one of the initiatives Purdue is undertaking to help reduce the abuse and diversion of prescription medications. Purdue also supports prescriber and patient education as part of a comprehensive approach to address misuse, abuse and diversion of opioid pain medicines, while ensuring that these medications remain accessible for patients with moderate to severe, chronic pain when appropriate. Information on the shared REMS is available at www.ER-LA-opioidREMS.com.

For more information about Purdue’s efforts to prevent and reduce prescription drug abuse, go to www.rxsafetymatters.org.

The professional product labeling for OxyContin^® Tablets contains the following boxed warning:

Indications and Usage
OxyContin is indicated for the management of moderate to severe pain when a continuous, around-the-clock opioid analgesic is needed for an extended period of time.

Limitations of Use

OxyContin is not for use:

• As an as-needed (prn) analgesic
• For pain that is mild or not expected to persist for an extended period of time
• For acute pain
• In the immediate postoperative period
• For postoperative pain, unless the patient is already receiving chronic opioid therapy prior to surgery, or if the postoperative pain is expected to be moderate to severe and persist for an extended period of time

OxyContin 60 mg and 80 mg tablets, a single dose greater than 40 mg, or a total daily dose greater than 80 mg are only for patients in whom tolerance to an opioid of comparable potency is established. Patients considered opioid tolerant are those who are taking at least 60 mg oral morphine/day, 25 mcg transdermal fentanyl/hour, 30 mg oral oxycodone/day, 8 mg oral hydromorphone/day, 25 mg oral oxymorphone/day, or an equianalgesic dose of another opioid for one week or longer.

Contraindications
OxyContin is contraindicated in patients with:

• Significant respiratory depression
• Acute or severe bronchial asthma in an unmonitored setting or in the absence of resuscitative equipment
• Known or suspected paralytic ileus and gastrointestinal obstruction
• Hypersensitivity (e.g., anaphylaxis) to oxycodone

Additional Safety Information
Respiratory depression is the chief hazard of opioid agonists, including OxyContin. Respiratory depression is more likely to occur in elderly, cachectic, and debilitated patients, and patients with chronic pulmonary disease; therefore closely monitor these patients.

Hypotension, and profound sedation, coma or respiratory depression may result if OxyContin is used concomitantly with other CNS depressants (e.g., sedatives, anxiolytics, hypnotics, neuroleptics, muscle relaxants, other opioids). When considering the use of OxyContin in a patient taking a CNS depressant, assess the duration of use of the CNS depressant and the patient’s response, including the degree of tolerance that has developed to CNS depression. If OxyContin therapy is to be initiated in a patient taking a CNS depressant, start with a lower OxyContin dose than usual and monitor patients for signs of sedation and respiratory depression and consider using a lower dose of the concomitant CNS depressant.

Use caution when prescribing OxyContin for patients who have difficulty swallowing or have underlying GI disorders that may predispose them to obstruction. Instruct patients not to pre-soak, lick or otherwise wet OxyContin Tablets prior to placing in the mouth, and to take one tablet at a time with enough water to ensure complete swallowing immediately after placing in the mouth.

OxyContin may increase the risk of serious adverse reactions such as those observed with other opioid analgesics, including respiratory depression, apnea, respiratory arrest, circulatory depression, hypotension, or shock. The most common adverse reactions (>5%) reported by patients in clinical trials comparing OxyContin with placebo are: constipation, nausea, somnolence, dizziness, vomiting, pruritus, headache, dry mouth, asthenia, and sweating.

Full prescribing information for OxyContin® is available at www.purduepharma.com/OxyContinPI

Contact:

Libby Holman
Associate Director
Public Affairs
Tel: 203-588-7670
Cell: 203-609-1291
Email: libby.holman@pharma.com

James Heins
Senior Director
Public Affairs
Tel: 203-588-8069
Cell: 203-856-2121
Email: james.heins@pharma.com

March 4, 2013, Stamford, CT. – This March, Senokot® Tablets and Senokot-S® Tablets are launching the “Senokot® and Senokot-S® Tablets Overnight Relief Sweepstakes,” a three‐month national sweepstakes promotion in which anyone age 18 or older can enter to win an array of deluxe prizes, such as Hyatt Hotel gift cards, Phillips 22” flat-screen TVs, Kindle Touches, iPod Nanos and more. While Senokot® Tablets provide overnight relief to those who occasionally suffer from constipation, which may be associated with diet, lifestyle changes, or travel, Senokot-S® Tablets can be an option for those who suffer from occasional constipation which may be associated with certain medications.

“Our goal is to make the topic of occasional constipation more mainstream so that people are more open to discussing it with their doctors or pharmacists”, explains Charlene Bailey, Director, Product Management for Purdue Products L.P. According to a recent survey conducted by Russell Research for Purdue Products L.P. in November 2012, of 1,023 women ages 18 and older, 53% of those polled agree that occasional constipation is an embarrassing topic to talk about with friends and family, while almost half also find the topic embarrassing to discuss with physicians and other health care professionals.

The survey revealed many misconceptions about occasional constipation. Forty-one percent of women polled think that occasional constipation is not a condition they need to worry about at their age. Although older adults are more likely to report problems with constipation than younger adults, poor diet, lack of physical activity, certain medications and dehydration can be the cause of the condition at any age.1 In addition, only one in three women knew it could be the result of surgery.2

“Based on the popularity of last year’s promotion, we are bringing back the Senokot Overnight Relief Sweepstakes. However the 2013 promotion differs slightly from the previous promotion by offering people a chance to choose from an array of prizes that they can win” stated Bailey. The promotion will also continue to help increase the conversation about occasional constipation so that people can seek appropriate treatment options.

By the end of the sweepstakes period, over $50,000 in prizes will be given away. The promotion kicks off March 3, 2013 and winners will be selected randomly on a daily basis. When entering, consumers can pick the prize they want to win from a selection of three new prizes daily – so entrants can “shop” for the prize they want most. Consumers can enter as many times as they like by visiting www.senokotovernightrelief.com, a special promotional website.

Senokot® Tablets are made from a natural vegetable laxative ingredient, and provide gentle, overnight relief from occasional constipation. Please read full product label before use. For more information on the Senokot® and Senokot-S Tablets Overnight Relief Sweepstakes, visit www.SenokotOvernightRelief.com and follow it on Twitter @SenokotSweeps and Facebook (SenokotSweeps).

The Senokot® and Senokot-S® Tablets Overnight Relief Sweepstakes
The sweepstakes begins March 3, 2013, and runs through May 31, 2013. Consumers can enter online online via a special promotional website (SenokotOvernightRelief.com) where they will be able to choose from a selection of three prizes, or offline by mailing their contact information to Senokot®and Senokot-S® Tablets Overnight Relief, P.O. Box 724, Southport, CT 06890. The sweepstakes will run for 13 weeks in the U.S. and Puerto Rico, with over $50,000 in prizes given by the end of the promotion period. Winners will be selected randomly on a daily basis. Prizes include Hyatt Hotel gift cards, Phillips 22” flat-screen TVs, iPod Nanos, Kindle Touches, and more.

The Purdue Products L.P. Laxative Brands
The Purdue Products L.P. Laxative Brands are dedicated to providing consumers with options to help relieve occasional constipation. Senokot® Tablets and Colace® Capsules have been recommended by doctors and pharmacists for more than 5 decades for gentle relief from occasional constipation. Senokot-S® Tablets provide gentle, overnight relief from occasional constipation that may be associated with certain medications. Colace® Capsules are the #1 stool softener brand recommended by doctors and pharmacists. The Purdue Laxatives portfolio includes: Colace® Capsules, Peri‐Colace® Tablets, Senokot-S® Tablets, Senokot® Tablets, Senokot TO GO®, and SenokotXTRA® Tablets.

¹American Gastroenterological Association. (2010). Understanding Constipation. Retrieved December 5, 2012, from http://www.gastro.org/patient-center/digestive-conditions/constipation
² Data on File. Purdue Products. 2012

ElMindA and Purdue Pharma L.P. Enter Research Agreement to Develop Novel Diagnostics to Improve Pain Management

Collaboration Extends Use of ElMindA BNA™ Technology Research

Herzliya, Israel and Stamford, Conn. USA – January 29, 2013 – ElMindA – the developer of an innovative technology capable of providing drug developers with superior insights into the effect of therapeutic interventions on brain function – has entered into a strategic, multi-year research collaboration agreement with Purdue Pharma L.P., a leading developer of pharmacologic therapies to treat and manage pain.

The staged research collaboration will focus on pain diagnosis and management, through the development of objective assessments of analgesia as well as other subjective responses to treatment, and include several projects aimed at the discovery and development of new clinical diagnostic tests and biomarkers to manage pain and to enable the development of more effective pain treatments.
“We are extremely pleased to enter into this collaboration with Purdue Pharma that will apply our advanced Brain Networks Activation (BNA™) technology to research efforts for the development of better diagnostic tools and biomarkers for pain management,” said Ronen Gadot, CEO of ElMindA. “Partnering with Purdue Pharma is another significant step forward for ElMindA, marking an expansion of the company’s collaborations with pharma companies and the addition of pain management to the Company’s portfolio of therapeutic focus.”

ElMindA’s BNA™ technology combines the most advanced brain imaging tools with ElMindA’s proprietary algorithms and signal processing to produce unparalleled detail and precision of brain functional mapping.  In the area of drug development, the BNA™ technology can shed light on the dynamic functional changes in brain networks pre- and post-drug administration to reveal mechanisms of action, optimize drug dosages and identify responders and non-responders to therapies early in the drug development process.

As part of an expanding R&D innovation strategy, Purdue is broadening the scope of its research collaborations beyond drug discovery and development in order to identify opportunities that can enhance the overall quality of pain management. Purdue scientists are evaluating potential mapping systems to objectively assess pain, new applications and technologies for pain management, new technologies for controlling drug release, and methods to assess treatment compliance.

“We are very excited about this collaboration and look forward to leveraging ElMindA’s BNA™ technology in a combined effort to enhance the diagnosis, treatment and management of pain. This collaboration is another important effort towards advancing care for pain patients and further demonstrates Purdue’s commitment as a leader in the field of pain management,” said Dr. Craig Landau, Chief Medical Officer for Purdue.

Clinical diagnostic tests to improve pain management and biomarkers for drug development resulting from the collaboration will be used and commercialized by ElMindA and/or Purdue.

About ElMindA:  ElMindA was founded in 2006 with the vision of revolutionizing the management of brain disorders and injuries by transforming state-of-the-art neuroscience into bed-side clinical practice, opening a new window into functionality of the brain.  The company seeks to dramatically improve clinical decision-making for Central Nervous System (CNS) disease management through wide utilization of its BNA™ testing as an objective measurement of brain function, dysfunction, disease progression and recovery. The ElMindA BNA™ technology is currently being used for drug development research with leading pharmaceutical companies and in research with prominent academic research centers throughout the U.S. and Europe.   In 2012,ElMindA submitted the technology for FDA clearance. The technology is not currently cleared for clinical use.

About Purdue Pharma L.P:  Purdue Pharma and its associated U.S. companies are privately-held pharmaceutical companies known for pioneering research on persistent pain. Headquartered in Stamford, CT, Purdue Pharma is engaged in the research, development, production, and distribution of both prescription and over-the-counter medicine and hospital products. Additional information about Purdue can be found at www.purduepharma.com.

Contact:

For Purdue Pharma L.P.
James Heins
Senior Director, Public Affairs
Purdue Pharma L.P.
Tel: 203-588-8069
Mobile:  203-856-2121
Email:   james.heins@pharma.com

For ElMindA:
Nicholas Weber
Vice President
FaegreBD Consulting
Tel: 317-237-1312
Email:   nicholas.weber@FaegreBD.com ]]> http://www.purduepharma.com/news-media/2013/01/elminda-and-purdue-pharma-l-p-enter-research-agreement-to-develop-novel-diagnostics-to-improve-pain-management/feed/ 0 http://www.purduepharma.com/news-media/2013/01/four-cities-win-grants-for-outstanding-prescription-drug-abuse-prevention-initiatives/ http://www.purduepharma.com/news-media/2013/01/four-cities-win-grants-for-outstanding-prescription-drug-abuse-prevention-initiatives/#comments Mon, 21 Jan 2013 16:27:13 +0000 admin http://www.purduepharma.com/?p=1733 Winners Recognized at 81^st Winter Meeting in Washington, DC

WASHINGTON, D.C. — Today, The United States Conference of Mayors (USCM) announced the winners of the 2013 Safeguard My Meds Prescription Drug Abuse Recognition Program, during the 81^st Winter Meeting in Washington, D.C.  Awards were given to outstanding local initiatives that have the greatest potential to reduce the misuse and abuse of prescription drugs, particularly among young people.

Grants were made to Mayoral-based initiatives in four cities:

• Asheville, NC
• Baltimore, MD
• Madison, WI
• New Bedford, MA

The grant program is the latest initiative in a four-year partnership between USCM and Purdue Pharma, L.P., with the goal supporting and/or enhancing existing prescription drug abuse prevention programs in America’s cities, as well as encouraging the development of new and innovative programs.  The successful USCM/Purdue Pharma partnership began in 2009 with a nationwide public awareness campaign, featuring Mayoral PSAs on the dangers of prescription drug abuse, and offering simple steps parents can take to protect their children by properly storing and disposing of medication in the home.  To date, Mayors have recorded more than 200 radio and television PSAs, which have reached an audience of millions in cities across the country.

“I am proud to be a part of this important partnership with Purdue Pharma,” said Tom Cochran, U.S. Conference of Mayors CEO and Executive Director.  “Together, The Conference of Mayors and Purdue Pharma have taken a national leadership role in the fight against prescription drug abuse, particularly among our young people, and these awards are an important step in supporting the efforts of mayors on the ground, at the local level.”

Grant awards were divided into two categories: small city (those with populations of less than 100,000) and large city (those with populations of 100,000 or more).  First and second place awards were given in both categories.  An independent panel of judges evaluated the applications based on innovation, creativity, mayoral involvement and potential impact.

”We congratulate the mayors who have won this year’s award and applaud the efforts of all the mayors who participated throughout the years in the USCM Safeguard My Meds public education campaign,” said Pamela Bennett, RN, BSN, Executive Director of Healthcare Alliance Development at Purdue Pharma.  “USCM has been a valuable partner in helping to educate the public about the importance of safe storage and disposal of medication, and we look forward to our continued partnership.”

For more information, please see a listing of program descriptions for the winning cities below.

The United States Conference of Mayors is the official nonpartisan organization of cities with populations of 30,000 or more. There are more than 1,200 such cities in the country today, and each city is represented in the Conference by its chief elected official, the mayor. Find us online at usmayors.org, facebook.com/usmayors, or follow us on Twitter at twitter.com/usmayors.

Purdue Pharma L.P. , a privately held pharmaceutical company founded by physicians, is focused on meeting the needs of healthcare providers and the patients in their care. We are known for our pioneering research on pain, a principal cause of human suffering.  For more information about Purdue’s programs and partnerships to combat prescription drug abuse, visit www.RxSafetyMatters.org.   

Small City

1^st Place ($10,000):     New Bedford, MA, Mayor Jon Mitchell: “Pathways Opiate Overdose Coalition”

The Pathways Coalition, under the leadership of Mayor Jon Mitchell, will utilize a team of young people aged 14‐24 as peer educators, to provide education and training to the community about prescription drug safety, in line with the guidelines set out by the Office of National Drug Control Policy (ONDCP). The program will provide a minimum of 12 presentations/appearances throughout the community, as well as a social marketing campaign that will utilize various electronic media outlets and web presence to promote the prescription safety program and reach all families in New Bedford with the message.

“Educating youth about the dangers of prescription drug misuse and abuse is critical to our efforts to combat substance abuse and the illicit drug trade in our community.  In New Bedford, public health officials, drug treatment providers, and law enforcement remain committed to working together to address this public health challenge.  One key feature of this program is that it engages and educates young people to teach their peers and empowers youth to become leaders who can help solve their own problems. I’m pleased that the United States Conference of Mayors and Purdue Pharma have recognized this program and I look forward to it serving as a model for other cities across the country.”

– New Bedford, MA Mayor Jon Mitchell

2^nd Place ($5,000):       Asheville, NC, Mayor Terry Bellamy: “Partnership for Substance Free Buncombe County”

The Partnership for Substance Free Youth Buncombe County  has partnered with Ingles, a chain of grocery stores with more than 200 locations in the southeastern United States, to purchase and distribute over 10,000 special bright yellow “Drop Off Your Drugs” bags, and made them available on checkout counters at all Buncombe County Ingles stores. The program works as follows: customers and local residents pick-up a free yellow bag, fill it with prescription pills they no longer use, and return it to one of a number of drop-off stations around the county.

“We are grateful to be selected as an award recipient for the USCM/Purdue Pharma Prescription Drug Abuse Awareness grants.  We are proud to be a member of the nationally recognized Partnership for Substance Free Youth in Buncombe, and we look forward to continuing the collaborative efforts and in community education toward our goal of realizing a Drug Free Buncombe County.  These funds will enhance the outreach and education within our community in highlighting the dangers associated with the abuse of prescription drugs.”

 – Asheville Mayor Terry Bellamy

Large City

1^st Place ($10,000):     Madison, WI Mayor Paul Soglin: “Stop the Overdose Epidemic”

The primary objective of the “Stop the Overdose Epidemic” initiative is to measurably reduce drug-related death and hospitalization. Because the prescription drug abuse/misuse problem touches every population group, customized prevention messages will be developed for youth and a variety of other target populations, including people of all ages prescribed opiates for acute or chronic pain;  clinicians and dentists who prescribe opiates, substance abuse treatment providers, people in recovery and their families, on navigating treatment options; first responders and addicts regarding utilization of rescue doses of naloxone; judicial and law enforcement communities on programs that reduce attendant crime while treating addiction (e.g. drug court); and the general public on safe use, storage and disposal of all medicines.

“This funding will help us continue our work to educate  the community on the dangers of prescription drug  abuse.  We have a coalition of health care providers, public health nurses, police, social workers and others working together on this very important issue.  This additional funding will help save lives.”

– Madison, WI Mayor Paul Soglin

2^nd Place ($5,000):       Baltimore, MD, Mayor Stephanie C. Rawlings-Blake:

“LIVE RIGHT DO RIGHT Substance Abuse Prevention Education”

The “Live Right Do Right Program” is a substance abuse prevention education program for adolescents and teenagers.  The program is designed to educate and empower youth to make informed decisions, based on an evidence-based curriculum which promotes healthy alternatives to risky behavior. The curriculum provides students with life skills training techniques , as well as support and family counseling when needed.  After completion of the course student participants will be paired with a qualified mentor for a period of one year.

“We are grateful to the U.S. Conference of Mayors and Purdue Pharma for recognizing the work of the Mario Do Right Foundation’s effort to educate young people about the dangers of prescription drug abuse. Their partnership provides vital outreach and assistance to young people and families in our communities.”

– Baltimore Mayor Stephanie Rawlings-Blake

The National Community Pharmacists Association (NCPA) and Purdue Pharma L.P. are working together to remind parents, grandparents, and other family members about simple – yet important – steps that can be taken to protect prescription medicines this holiday season through their national educational initiative, Safeguard My Meds.

“As a pharmacist and mother, I understand how critical it is to keep prescription medicines from falling into the wrong hands,” said Michele Belcher R.Ph, third vice president of the National Community Pharmacists Association. “Every day more than 2,500 teenagers abuse prescription medication for the first time. Proper storage and disposal of prescription medicines in the home can play a vital role in preventing misuse and abuse.”²

A national survey showed an overwhelming majority of Americans (94%) understand it is extremely or very important to safely store and dispose of prescription medicine, however, many aren’t doing enough to protect their medicines:³

• More than two-thirds (68%) indicated they keep prescription medicine in an unlocked cabinet, closet or drawer in their household.
• Respondents most frequently said they store prescription medicine in the bathroom (53%) and kitchen (49%) – two potentially vulnerable, high-traffic areas.

Belcher points out that there are several easy steps that can be taken to protect prescription medicines, including:

• Use a locked storage container to store prescription medicines at greater risk of being abused – pain relievers, tranquilizers, stimulants and depressants. These medicines are targets for theft by anyone who enters your home, so extra precautions should be taken.
• Keep track of medications with the Medicine Inventory Sheet – one is available on www.SafeguardMyMeds.org.
• Take inventory of prescription medicines at least twice a year, such as when you change your clocks in the spring and fall.

Go to www.SafeguardMyMeds.org to access additional information on safe medicine storage through downloadable print, video, and online materials. Visitors are also encouraged take the Personal Responsibility Pledge and make a commitment to safeguard their prescription medicine.

About the Survey

The survey was conducted by Opinion Research Corporation – Infogroup/ORC, a national research firm on behalf of the National Community Pharmacists Association and Purdue Pharma to assess knowledge and behavior about prescription medicine safety and disposal. Telephone interviews among a projectable national sample of 1,010 adults, including 503 men and 507 women 18 years of age and older, living in private households in the continental United States, were conducted between August 27-30, 2010. The margin of error for results based on the entire sample of 1,010 is plus or minus three percentage points.

About the National Community Pharmacists Association (NCPA)

NCPA represents the interests of America’s community pharmacists, including the owners of more than 23,000 independent community pharmacies. Together they represent a $93 billion health care marketplace, dispense nearly 40% of all retail prescriptions, and employ more than 315,000 people, including 62,400 pharmacists. Independent community pharmacists are readily accessible medication experts who can help lower health care spending. To learn more go to www.ncpanet.org or read NCPA’s blog, The Dose, at http://ncpanet.wordpress.com.

About Purdue Pharma L.P.

Purdue Pharma and its associated U.S. companies are privately-held pharmaceutical companies known for pioneering research on persistent pain. Headquartered in Stamford, CT, Purdue Pharma is engaged in the research, development, production, and distribution of both prescription and over-the-counter medicine and hospital products. Additional information about Purdue can be found at www.purduepharma.com.

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1. Substance Abuse and Mental Health Services Administration (SAMHSA), Office of Applied Studies, National Survey on Drug Use and Health (NSDUH), 2008.
2. Office of National Drug Control Policy, Prescription for Danger, Jan. 2008
3. Safeguard My Meds survey data set. 2010.

NASCSA will manage the solicitation, review and funding of grant proposals. State government agencies or departments will be selected based on an independent review by the NASCSA Special Projects Committee, which consists of association members with expertise in the fields of prescription drug abuse and diversion and prescription drug monitoring programs. Purdue Pharma will have no input into the final selection process.

“State budgets are shrinking, but the abuse and diversion of prescription drug problem is a growing concern,” said Ronald J. Klein, RPh, executive officer of the Vermont Board of Pharmacy. “Purdue Pharma’s funding of state prescription drug monitoring programs will help keep these medications out of the wrong hands while ensuring legitimate patients have access to the medications they need.”

The grant monies are scheduled to be distributed by NASCSA to various state government departments or agencies with the ability to accept private funding expressly for their state prescription monitoring program by the end of 2012.

“Since 2001, Purdue Pharma has been working to support the implementation of appropriately-designed prescription monitoring programs as one way to help reduce abuse and diversion of prescription medications,” said Alan Must, vice president of state government and public affairs at Purdue Pharma. “Reducing the abuse of prescription medications will take the combined and coordinated efforts of healthcare professionals, law enforcement, government agencies and local communities. NASCSA is an organization that is uniquely qualified to address the issues of prescription drug abuse from a broad inclusive perspective and we are delighted to provide this funding for this initiative.”

The National Association of State Controlled Substances Authorities is a 501(C)(3) non-profit educational organization whose primary purpose is to provide a continuing mechanism through which state and federal agencies can work to increase the effectiveness and efficiency of efforts to prevent and control drug diversion and abuse. NASCSA can be found at
http://www.nascsa.org.

Purdue Pharma L.P. and its associated U.S. companies are privately-held pharmaceutical companies known for pioneering research on persistent pain. Headquartered in Stamford, CT, Purdue Pharma is engaged in the research, development, production, and distribution of both prescription and over-the-counter medicines and hospital products. Additional information about Purdue can be found at www.purduepharma.com.

Contact:

Kathy Keough
NASCSA
617-347-1455
kathykeough@nascsa.org

Libby Holman
Purdue Pharma L.P.
203-588-7670
libby.holman@pharma.com

Citing recent research showing that every day, more than 2,500 teenagers abuse prescription medication for the first time,¹ Mayor Berry called on the community to help raise awareness about this growing public health problem.

“Many young people mistakenly think that it is safer to misuse prescription medications than illegal street drugs,” said Mayor Berry. “There seems to be less social stigma attached to misusing medications so it seems more acceptable to teens. Parents often are unaware that young people are abusing medications.”

According to the National Survey on Drug Use and Health, 12 to 17 year olds abuse prescription drugs more than they abuse ecstasy, crack/cocaine, heroin, and methamphetamine combined.^1, Prescription drug abuse by teens is exceeded only by marijuana use, and there are just as many new abusers (initiates) 12 and older of pain relievers as there are for marijuana.¹ The prescription drugs most commonly abused by teens are painkillers, prescribed to treat pain; depressants, such as sleeping pills or anti-anxiety drugs; and stimulants, mainly prescribed to treat attention-deficit hyperactivity disorder (ADHD).¹ Sixty percent of teens who have abused prescription painkillers did so before age 15.¹

With the support of local healthcare professionals, businesses, and families, including the U.S. Conference of Mayors, the National Community Pharmacists Association, the Greater Albuquerque Medical Association and the pharmaceutical company Purdue Pharma L.P., Mayor Berry is encouraging people to take steps to safeguard medicines in the home and become better educated on problem of prescription drug abuse so that they can talk to their children and help them avoid the dangers.

“It is time for all of us to call attention to this problem and work together to curb the abuse of prescription medications,” said Dr. Jeremy Gleeson, president of the Greater Albuquerque Medical Association. “The first place to begin is right at home. People can help keep medicines out of the wrong hands by monitoring the contents of their medicine cabinet. They should also encourage friends and relatives to safeguard medications in their homes and consult their community pharmacist about how to properly dispose of medications that are no longer needed.”

In addition to warning the public about the dangers of abusing prescription medications, medical experts cautioned about the collateral damage that is caused by medication abuse.

“It is very important to remember that prescription medications have a legitimate medical purpose and can be very beneficial when used properly under the doctor’s supervision,” said Gleeson. “The abuse of prescription medications often makes it difficult for people who need these medicines to get the treatment they deserve.”

Safeguard My Meds is supported by the U.S. Conference of Mayors, the National Community Pharmacists Association and pharmaceutical company Purdue Pharma L.P. to reduce the abuse of prescription medications. Visit www.safeguardmymeds.org for more information on the safe storage and disposal of prescription medications.

The U.S. Conference of Mayors is the official nonpartisan organization of cities with populations of 30,000 or more. There are 1,210 such cities in the country today, each represented in the Conference by its chief elected official, the Mayor. The primary roles of The U.S. Conference of Mayors are to promote the development of effective national urban/suburban policy; strengthen federal-city relationships; ensure that federal policy meets urban needs; provide mayors with leadership and management tools; and create a forum in which mayors can share ideas and information. Find us on facebook.com/usmayors or follow up on Twitter at twitter.com/usmayors

The National Community Pharmacists Association (NCPA^®) represents the interests of America’s community pharmacists, including the owners of more than 23,000 independent community pharmacies. Together they represent a $93 billion health care marketplace, dispense nearly 40% of all retail prescriptions, and employ more than 315,000 people, including 62,400 pharmacists. Independent community pharmacists are readily accessible medication experts who can help lower health care spending. To learn more go to www.ncpanet.org or read NCPA’s blog, The Dose, at http://ncpanet.wordpress.com.

The Greater Albuquerque Medical Association is a membership organization of licensed doctors of medicine and doctors of osteopathic medicine residing and practicing in the greater Albuquerque area. The organization’s mission is to promote excellence in patient care by identifying and solving physician practice problems in any practice environment through advocacy, education and collegiality.

Purdue Pharma L.P. and its associated U.S. companies are privately-held pharmaceutical companies known for pioneering research on persistent pain. Headquartered in Stamford, CT, Purdue Pharma is engaged in the research, development, production, and distribution of both prescription and over-the-counter medicine and hospital products. Additional information about Purdue can be found at www.purduepharma.com.

¹ Office of National Drug Control Policy, Prescription for Danger, Jan. 2008

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Contact:
Dayna Gardner
505-414-3438
gardner@cabq.gov

Stamford, CT – July 9, 2012 – The U.S. Food and Drug Administration (FDA) is requiring opioid analgesic companies to implement a new, shared Risk Evaluation & Mitigation Strategy (REMS) for all extended-release and long-acting opioid pain medications to ensure that the benefits continue to outweigh the risks of adverse outcomes (addiction, unintentional overdose, and death) resulting from inappropriate prescribing, abuse, and misuse. The principal components of this REMS are:

• prescriber training on all ER/LA opioid analgesics,
• a Patient Counseling Document on Extended-Release and Long-Acting Opioid Analgesics (PCD), and
• a Medication Guide for each ER/LA opioid analgesic drug product.

These components are intended to help healthcare professionals better understand the risks and benefits of selecting and prescribing these important medicines, and to educate patients about how to use as directed, their risks, and proper storage and disposal.

Purdue supports the goals of enhanced prescriber and patient education as part of a comprehensive approach necessary to address the misuse, abuse, and diversion of prescription medicines, while ensuring these medications remain accessible for people with chronic, moderate to severe pain, when appropriate.

Purdue first developed and implemented risk management programs for its opioid products in 1998, to provide prescribers with information on proper patient selection and assessment, when considering the use of opioid analgesics. The company has continually provided resources and tools to healthcare professionals to help them recognize and minimize diversion, abuse and addiction. The company launched FDA-approved product-specific REMS for OxyContin^® (oxycodone HCl controlled release) Tablets CII and Butrans^® (buprenorphine) Transdermal System CIII in 2010. The new shared REMS that is being required by the FDA was developed with support and input from the medical community, patient advocacy groups, and the pharmaceutical industry, and will supersede the individual product REMS for these and other extended-release and long-acting opioid medications. More information on the new shared REMS will soon become available at www.ER-LA-opioidREMS.com or on the FDA web site at www.fda.gov/Drugs/DrugSafety/InformationbyDrugClass/ucm163647.htm.

The misuse, abuse and diversion of prescription pain medicines – as well as untreated and undertreated chronic pain – are serious, complex, and interrelated public health issues. Purdue is committed to reduce and prevent the abuse of prescription medicines by supporting healthcare professional and public education; promoting proper storage and disposal of medications in the home; encouraging better monitoring and tracking of medicines; and assisting law enforcement efforts to combat illegal diversion of prescription medication.

For more information about the company’s efforts to address prescription medicine abuse and diversion, visit www.rxsafetymatters.org.

The professional prescribing information for OxyContin Tablets contains the following boxed warning:

INDICATIONS AND USAGE

OxyContin is indicated for the management of moderate to severe pain when a continuous,
around-the-clock opioid analgesic is needed for an extended period of time.

Limitations of Use

OxyContin is not for use:

• As an as-needed (prn) analgesic
• For pain that is mild or not expected to persist for an extended period of time
• For acute pain
• In the immediate postoperative period (the first 24 hours following surgery) for patients not previously taking the drug, because its safety in this setting has not been established.
• For postoperative pain unless the patient is already receiving chronic opioid therapy prior to surgery, or if the postoperative pain is expected to be moderate to severe and persist for an extended period of time.

OxyContin 60 mg and 80 mg tablets, a single dose greater than 40 mg, or a total daily dose greater than 80 mg are only for patients in whom tolerance to an opioid of comparable potency is established. Patients considered opioid tolerant are those who are taking at least 60 mg oral morphine/day, 25 mcg transdermal fentanyl/hour, 30 mg oral oxycodone/day, 8 mg oral hydromorphone/day, 25 mg oral oxymorphone/day, or an equianalgesic dose of another opioid for one week or longer.

CONTRAINDICATIONS

OxyContin is contraindicated in patients with:

• Significant respiratory depression
• Acute or severe bronchial asthma in an unmonitored setting or in the absence of resuscitative equipment
• Known or suspected paralytic ileus and gastrointestinal obstruction
• Hypersensitivity (e.g., anaphylaxis) to oxycodone [see Adverse Reactions (6.2)]*

The Full Prescribing Information for OxyContin, including the Boxed Warning and the Medication Guide, is available at http://www.purduepharma.com/pi/prescription/OxycontinPI.pdf.

The professional prescribing information for Butrans Transdermal System contains the following boxed warning:

INDICATIONS AND USAGE

BUTRANS is indicated for the management of moderate to severe chronic pain when a
continuous, around-the-clock opioid analgesic is needed for an extended period of time.

Limitations of Use

BUTRANS is not for use:

• As an as-needed (prn) analgesic
• For pain that is mild or not expected to persist for an extended period of time
• For acute pain
• For postoperative pain unless the patient is already receiving chronic opioid therapy prior to surgery or if the postoperative pain is expected to be moderate to severe and persist for an extended period of time

CONTRAINDICATIONS

BUTRANS is contraindicated in patients with:

• Significant respiratory depression
• Acute or severe bronchial asthma in an unmonitored setting or in the absence of resuscitative equipment
• Known or suspected paralytic ileus
• Hypersensitivity (e.g., anaphylaxis) to buprenorphine [see Warnings and Precautions (5.12), and Adverse Reactions (6)]*

*[Referenced sections and numbers in parentheses refer to sections of the Full Prescribing Information]

The Full Prescribing Information for Butrans, including the Boxed Warning and the Medication Guide, is available at http://app.purduepharma.com/xmlpublishing/pi.aspx?id=b.

About Purdue Pharma L.P.

Purdue Pharma L.P. and its associated U.S. companies are privately-held pharmaceutical companies known for pioneering research on persistent pain. Headquartered in Stamford, CT, Purdue Pharma is engaged in the research, development, production, and distribution of both prescription and over-the-counter medicines and hospital products. Additional information about Purdue can be found at www.purduepharma.com.

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James Heins
203-588-8069 (Office)
203-856-2121 (Mobile)
james.heins@pharma.com

Libby Holman

203-588-7670 (Office)

203-609-1291 (Mobile)

libby.holman@pharma.com