Purdue Pharma L.P. To Present Data from Research Studies at PAINWeek 2014 Annual Conference

Stamford, Conn. – Aug. 27, 2014 – Purdue Pharma L.P. will present results from a number of clinical and non-clinical research and, in addition, will deliver an oral presentation on abuse deterrence technologies in opioid analgesics during the PAINWeek national conference Sept. 2-6, 2014 in Las Vegas.

In a presentation sponsored by Purdue on Thursday, Sept. 4, J. David Haddox, DDS, MD, Vice President of Health Policy at Purdue Pharma will present “Innovative Formulations Designed to Deter the Abuse of Opioid Analgesics: Overview of Emerging Technologies” in the Brera Ballroom of The Cosmopolitan from 2:50–3:50 p.m. PDT. The presentation will focus on the evolving technology used to incorporate abuse-deterrent characteristics into formulations of opioid medications and the basis for this need.

Purdue will also present posters at the conference on Thursday, Sept. 4 from 6:30–8:30 p.m. PDT:

Title

Authors

Routes of Administration and Frequency of Abuse of OxyContin® and Immediate-release Oxycodone in a Rural Kentucky County Following Introduction of Reformulated OxyContin

DeVeaugh-Geiss A

Decrease in Diagnosed Opioid Abuse, Addiction, or Poisoning after OxyContin with Abuse-deterrent Characteristics was Introduced in a Commercially Insured Population

Coplan PM, Kadakia A

Comparison of the Risk of Opioid Overdose Among Patients Prescribed Extended-release Opioids versus Immediate-release Opioid Analgesics

Coplan PM

Trends in Abuse and Diversion in Multiple Surveillance Systems Three Years After introduction of reformulated OxyContin

Chilcoat H, Coplan PM

Comparing the Prevalence and Healthcare Costs of Diagnosed Opioid Abuse Among Commercially-insured Beneficiaries Using Two Distinct Commercial Claims Databases

Rice JB, Kirson NY, Shei A, Enloe CJ, Cummings AK, Bodnar K, Burnbaum HG, Holly P, Ben-Joseph R

Methods to Estimate the Prevalence and Healthcare Costs of Undiagnosed Opioid Abuse Among Commercially-insured Individuals

Shei A

Epidemiology of Conditions Associated with Pain and the Use of Analgesic and Non-Analgesic Treatments in Pediatrics

Wallace L

Analysis of Pre-screening Data from Pediatric Pain Trials

Wallace L, Rodenas E, Matsuno R, Kadakia A

Is the Buprenorphine Patch associated with Lower Overdose Rates than Other Opioid Analgesics among Pain Patients?

Coplan PM

Comparison of Abuse Rates of Buprenorphine Patch versus other Extended-release Opioid Analgesics in the National Poison Data System Database

Coplan PM

An Evaluation of the FDA Adverse Event Reporting System Database for a Signal of Disproportionate Reporting of Cardiac Arrhythmia Associated with the Buprenorphine Transdermal System

Sessler N

Opioid Abuse/Dependence Symptoms and Gender

DeVeaugh-Geiss A

 

Posters on Purdue’s investigational once-daily, single-entity, hydrocodone bitartrate formulation will also be presented during the poster session Thursday from 6:30–8:30 p.m. PDT:

Title

Authors

In vitro Assessment of the Effects of Alcohol on the Release Rate of Hysingla® ER, an Investigational, Once-daily, Single-entity, Hydrocodone Bitartrate Formulation

Giordano J, Huang H, Kianto J, Das S

Intranasal Abuse Potential Study of an Investigational, Once-Daily, Single-Entity, Extended-Release Hydrocodone Tablet (Hysingla ER) in Recreational Opioid Users

Harris S, Colucci S, Kapil R, Cipriano A, Geoffory P, Hopyan T, Levy-Cooperman N

Oral Abuse Potential Study of an Investigational, Once-Daily, Single-Entity, Extended-Release Hydrocodone Tablet (Hysingla ER) in Recreational Opioid Users

Harris S, Colucci S, Kapil R, Cipriano A, Geoffory P, Hopyan T, Levy-Cooperman N

No Hearing Impairment from an Investigational, Once-daily, Single-entity Hydrocodone Treatment (Hysingla ER): Results of 2 Phase-3 Studies

Kutz JW, Campbell K, Shoup A, Wen W, Lynch SY, He E, Ripa SR

Efficacy and Safety of an Investigational, Once-daily Hydrocodone (Hysingla ER) in CLBP

Wen W, Sitar S, Lynch SY, Ripa SR

Evaluation of an Investigational, Once-daily Hydrocodone (Hysingla ER) in Patient Subgroups

Wen W, Sitar S, Lynch SY, He E, Ripa SR

Evaluation of an Investigational, Once-daily Hydrocodone (Hysingla ER) in Users of Immediate-release Hydrocodone Combination Products

Wen W, Sitar S, Lynch SY, He E, Ripa SR

Long-term Safety and Effectiveness of an Investigational, Once-daily, Single-entity Hydrocodone, Formulated with Abuse Deterrent Properties (Hysingla ER) in Chronic Nonmalignant and Nonneuropathic Pain: Results of an Open-label Study

Wen W

Predictors of Long-term Immediate-release Hydrocodone/Acetaminophen Use Among a Commercially Insured Population

DeVeaugh-Geiss A

 

The Full Prescribing Information for OxyContin contains the following Boxed Warning:

WARNING: ADDICTION, ABUSE and MISUSE; LIFE-THREATENING RESPIRATORY DEPRESSION; ACCIDENTAL INGESTION; NEONATAL OPIOID WITHDRAWAL SYNDROME; and CYTOCHROME P450 3A4 INTERACTION

Addiction, Abuse, and Misuse
OXYCONTIN® exposes patients and other users to the risks of opioid addiction, abuse and misuse, which can lead to overdose and death. Assess each patient’s risk prior to prescribing OXYCONTIN and monitor all patients regularly for the development of these behaviors or conditions [see Warnings and Precautions (5.1)].

Life-Threatening Respiratory Depression
Serious, life-threatening, or fatal respiratory depression may occur with use of OXYCONTIN. Monitor for respiratory depression, especially during initiation of OXYCONTIN or following a dose increase. Instruct patients to swallow OXYCONTIN tablets whole; crushing, chewing, or dissolving OXYCONTIN tablets can cause rapid release and absorption of a potentially fatal dose of oxycodone [see Warnings and Precautions (5.2)].

Accidental Ingestion
Accidental ingestion of even one dose of OXYCONTIN, especially by children, can result in a fatal overdose of oxycodone [see Warnings and Precautions (5.2)].

Neonatal Opioid Withdrawal Syndrome
Prolonged use of OXYCONTIN during pregnancy can result in neonatal opioid withdrawal syndrome, which may be life-threatening if not recognized and treated, and requires management according to protocols developed by neonatology experts. If opioid use is required for a prolonged period in a pregnant woman, advise the patient of the risk of neonatal opioid withdrawal syndrome and ensure that appropriate treatment will be available [see Warnings and Precautions (5.3)].

Cytochrome P450 3A4 Interaction
The concomitant use of OXYCONTIN with all cytochrome P450 3A4 inhibitors may result in an increase in oxycodone plasma concentrations, which could increase or prolong adverse drug effects and may cause potentially fatal respiratory depression. In addition, discontinuation of a concomitantly used cytochrome P450 3A4 inducer may result in an increase in oxycodone plasma concentration. Monitor patients receiving OXYCONTIN and any CYP3A4 inhibitor or inducer [see Warnings and Precautions (5.14) and Clinical Pharmacology (12.3)].

Full prescribing information for OxyContin, including the Medication Guide and Boxed Warning is available at: www.purduepharma.com/oxycontinpi.

The Full Prescribing Information for Butrans contains the following Boxed Warning:

WARNING: ADDICTION, ABUSE, and MISUSE; LIFE-THREATENING RESPIRATORY DEPRESSION; ACCIDENTAL EXPOSURE; and NEONATAL OPIOID WITHDRAWAL SYNDROME

Addiction, Abuse, and Misuse

BUTRANS® exposes patients and other users to the risks of opioid addiction, abuse, and misuse, which can lead to overdose and death. Assess each patient’s risk prior to prescribing BUTRANS, and monitor all patients regularly for the development of these behaviors or conditions [see Warnings and Precautions (5.1) and Overdosage (10)].Life-Threatening Respiratory Depression
Serious, life-threatening, or fatal respiratory depression may occur with use of BUTRANS. Monitor for respiratory depression, especially during initiation of BUTRANS or following a dose increase. Misuse or abuse of BUTRANS by chewing, swallowing, snorting or injecting buprenorphine extracted from the transdermal system will result in the uncontrolled delivery of buprenorphine and pose a significant risk of overdose and death [see Warnings and Precautions (5.2)].

Accidental Exposure


Accidental exposure to even one dose of BUTRANS, especially by children, can result in a fatal overdose of buprenorphine [see Warnings and Precautions (5.2)].
Neonatal Opioid Withdrawal Syndrome

Prolonged use of BUTRANS during pregnancy can result in neonatal opioid withdrawal syndrome, which may be life-threatening if not recognized and treated, and requires management according to protocols developed by neonatology experts. If opioid use is required for a prolonged period in a pregnant woman, advise the patient of the risk of neonatal opioid withdrawal syndrome and ensure that appropriate treatment will be available [see Warnings and Precautions (5.3)].

 

Full prescribing information for Butrans, including the Medication Guide and Boxed Warning is available at www.purduepharma.com/butranspi.

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 chronic 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. Follow @PurduePharma on Twitter.

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