Abuse, Addiction, and Opioid Poisoning Results In Commercially-Insured Individuals Following Introduction of Reformulated OxyContin® (oxycodone HCl extended-release tablets) CII

Stamford, Conn. – March 20, 2015 6:00 p.m. ET – Data analysis shows reductions in abuse, addiction, and opioid poisoning diagnoses in the first year following the introduction of reformulated OxyContin® (oxycodone HCl extended-release tablets) CII incorporating abuse-deterrent properties. Results of the study, which evaluated medical claims data for commercially-insured individuals, are being presented this week at the American Academy of Pain Medicine 31st Annual Meeting in National Harbor, Maryland.In this retrospective analysis, researchers reviewed MarketScan commercial insurance claims data to assess the impact of reformulated OxyContin with abuse-deterrent properties on rates of diagnosed opioid abuse, addiction and poisoning among individuals prescribed opioid analgesics. The research found there was a 29 percent reduction in these diagnoses among individuals for whom OxyContin was the only opioid prescribed. Specifically the research showed the following:

  • Aggregate diagnosis rates for the cluster of opioid abuse, addiction, and poisoning decreased 12% (95% CI: -17%, -7%) among all individuals prescribed OxyContin, 29% (95% CI: -38%, -18%) among individuals prescribed OxyContin as their only opioid analgesic, and 10% (95% CI:-16%, -5%) among individuals prescribed OxyContin along with other opioids.
  • Changes for OxyContin alone (29% decrease in the three diagnoses of interest) were significantly different from those for comparator opioids—diagnosis rates increased 29% for ER oxymorphone, 8% for ER morphine, 15% for IR single-entity oxycodone (i.e., no acetaminophen), and 10% for IR hydromorphone.
  • Among patients dispensed multiple opioids in addition to OxyContin, the reduction in rate of the three diagnoses for OxyContin was not significantly different from other opioids.

The results presented today are consistent with findings from other surveillance programs, including reports from poison control centers and surveys of individuals in substance abuse treatment programs.

Purdue is conducting a range of epidemiological studies required by the US Food & Drug Administration (FDA). The data from these studies are being shared with the FDA on an ongoing basis and with the scientific community through scientific meetings and publications.

Purdue Pharma’s OxyContin is an extended-release oxycodone product that was originally approved by the FDA in 1995 and reformulated with abuse-deterrent properties to make the tablet more difficult to manipulate for misuse and abuse. Approved in April 2010, the product was shipped in August 2010 when shipments of the original formulation ceased. OxyContin has physicochemical properties expected to make abuse via injection and intranasal route difficult. However, abuse of OxyContin by injection and intranasal routes, as well as by the oral route is still possible.

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)].

Risks Specific to Abuse of OxyContin

OxyContin is for oral use only. Abuse of OxyContin poses a risk of overdose and death. The risk is increased with concurrent use of OxyContin with alcohol and other central nervous depressants. Taking cut, broken, chewed, crushed, or dissolved OxyContin enhances drug release and increases the risk of overdose and death. All patients treated with opioids require careful monitoring for signs of abuse and addiction, since use of opioid analgesic products carries the risk of addiction even under appropriate medical use.

With parenteral abuse, the inactive ingredients in OxyContin can be expected to result in local tissue necrosis, infection, pulmonary granulomas, and increased risk of endocarditis and valvular heart injury. Parenteral drug abuse is commonly associated with transmission of infectious diseases, such as hepatitis and HIV.

Additional Important Safety Information

Serious, life-threatening, or fatal respiratory depression has been reported with modified-release opioids, even when used as recommended, and if not immediately recognized and treated, may lead to respiratory arrest and death. The risk of respiratory depression is greatest during initiation of therapy or following a dose increase; therefore, closely monitor patients for respiratory depression. Proper dosing and titration of OxyContin are essential. Overestimating the OxyContin dose when converting patients from another opioid product can result in fatal overdose with the first dose.

Accidental ingestion of even one dose of OxyContin, especially by children, can result in respiratory depression and death due to an overdose of oxycodone.

Prolonged use of OxyContin during pregnancy can result in neonatal opioid withdrawal syndrome which may be life-threatening to the neonate if not recognized and treated, and requires management according to protocols developed by neonatology experts.

Hypotension, profound sedation, coma, respiratory depression, or death may result if OxyContin is used concomitantly with other CNS depressants, including alcohol or illicit drugs that can cause CNS depression. Start with 1/3 to 1/2 the usual dose of OxyContin, monitor patients for signs of sedation and respiratory depression, and consider using a lower dose of the concomitant CNS depressant.

Closely monitor elderly, cachectic, and debilitated patients, and patients with chronic obstructive pulmonary disease because of increased risk of life-threatening respiratory depression. Consider the use of alternative non-opioid analgesics in patients with chronic pulmonary disease if possible.

OxyContin may cause severe hypotension, including orthostatic hypotension and syncope in ambulatory patients. Monitor patients during dose initiation and titration. Avoid use of OxyContin in patients with circulatory shock. Monitor patients taking OxyContin who may be susceptible to the intracranial effects of CO2 retention for signs of sedation and respiratory depression. Avoid the use of OxyContin in patients with impaired consciousness or coma. OxyContin is contraindicated in patients with GI obstruction, including paralytic ileus. Use caution when prescribing OxyContin for patients who have difficulty swallowing, or have underlying GI disorders that may predispose them to obstruction. Consider use of an alternative analgesic in these patients.

OxyContin may cause spasm of the sphincter of Oddi. Monitor patients with biliary tract disease, including acute pancreatitis, for worsening symptoms.

OxyContin may aggravate convulsions in patients with convulsive disorders and may induce or aggravate seizures in some clinical settings. Monitor patients with a history of seizure disorders for worsened seizure control. Avoid the use of mixed agonist/antagonist or partial agonist analgesics in patients who have received or are receiving OxyContin, as they may reduce the analgesic effect and/or precipitate withdrawal. Do not abruptly discontinue OxyContin.

OxyContin may impair the mental and physical abilities needed to perform potentially hazardous activities such as driving a car or operating machinery.

Concomitant use of CYP3A4 inhibitors may prolong opioid effects. Use with CYP3A4 inducers may cause lack of efficacy or development of withdrawal symptoms. If co-administration is necessary, evaluate patients frequently and consider dose adjustments until stable drug effects are achieved.

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

About Purdue Pharma

Purdue Pharma 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.

Contact

James HeinsSenior Director, Public Affairsoffice: 203-588-8069

mobile: 203-856-2121

Email: james.heins@pharma.com

Bob JosephsonAssociate Director, Media Relationsoffice: 203-588-7114

mobile: 203-914-7741

email: robert.josephson@pharma.com