Purdue Pharma L.P. Files Petition With FDA Requesting Risk Management Plans For All Generic Forms Of OxyContin

STAMFORD, Conn., Jan. 9 /PRNewswire/ -- Purdue Pharma L.P. has filed a petition requesting the U.S. Food and Drug Administration (FDA) to withhold final approval of any generic forms of OxyContin(R) (oxycodone HCl controlled- release) Tablets until the generic companies implement appropriate risk management programs (RMPs) to minimize abuse, misuse and diversion of their product similar to Purdue's existing plan for OxyContin. The petition notes that the FDA and DEA agree that RMPs are an effective means of minimizing abuse and both have expressed concerns in the past about generic modified- release oxycodone products entering the market without adequate RMPs in place.

Purdue received FDA clearance to market OxyContin in December of 1995. When Purdue learned that illegal diversion and abuse of OxyContin was becoming prevalent in some regions of the country, the company took numerous steps -- many in cooperation with the FDA and the U.S. Drug Enforcement Administration (DEA) -- and committed hundreds of millions of dollars to combat this problem. The company worked with the FDA to develop and implement a comprehensive RMP to ensure safe and appropriate use of OxyContin and minimize its abuse, misuse and diversion, while still making the medication available to patients with a legitimate medical need. At an FDA advisory committee meeting on September 10th, 2003, an FDA official acknowledged that Purdue's RMP for one of its modified-release opioids is one of the best and most detailed plans developed to date.

"The distribution of generic modified-release oxycodone products without effective RMPs in place would likely result in an increase in injuries associated with misuse and abuse, as well as in crime associated with illegal trafficking of these medications," said Dr. David Haddox, Vice President of Health Policy for Purdue. "Since any generic long-acting oxycodone product will have the same abuse potential as OxyContin, we feel it is necessary for generic manufacturers to implement RMPs that match the elements and rigor of our program."

Purdue's RMP for OxyContin contains three key elements: 1) extensive education of prescribers, pharmacists and patients on proper pain management and the safe use of OxyContin in appropriate patients. Purdue is an acknowledged leader in pain management education and conducts thousands of educational programs each year. 2) active surveillance to detect signals of abuse, diversion, addiction and overdose. The company's RADARS(R) System can detect signals down to the three digit zip code in specific geographic areas. This system allows the company to gather information in a more timely manner than publicly available surveys of abuse. 3) a wide range of interventions, including support and education of law enforcement, targeted education of healthcare professionals on combating diversion and abuse, and awareness and prevention programs to the public in affected communities about the dangers of prescription drug abuse.

"Prescription drug abuse is a serious public health problem," Dr. Haddox stated. "The absence of effective RMPs for generic forms of OxyContin will dilute and compromise ongoing efforts to combat illegal trafficking and abuse and may ultimately raise barriers to the effective treatment of patients in need."

The petition will be available on the FDA web site at http://www.fda.gov/.

The professional product labeling for OxyContin(R) Tablets contains the following boxed warning:

WARNING:

OxyContin is an opioid agonist and a Schedule II controlled substance with an abuse liability similar to morphine.

Oxycodone can be abused in a manner similar to other opioid agonists, legal or illicit. This should be considered when prescribing or dispensing OxyContin in situations where the physician or pharmacist is concerned about an increased risk of misuse, abuse, or diversion.

OxyContin Tablets are a controlled-release oral formulation of oxycodone hydrochloride indicated for the management of moderate to severe pain when a continuous, around-the-clock analgesic is needed for an extended period of time.

OxyContin Tablets are NOT intended for use as a prn analgesic.

OxyContin 80 mg and 160 mg Tablets ARE FOR USE IN OPIOID-TOLERANT PATIENTS ONLY. These tablet strengths may cause fatal respiratory depression when administered to patients not previously exposed to opioids.

OxyContin TABLETS ARE TO BE SWALLOWED WHOLE AND ARE NOT TO BE BROKEN, CHEWED, OR CRUSHED. TAKING BROKEN, CHEWED, OR CRUSHED OxyContin TABLETS LEADS TO RAPID RELEASE AND ABSORPTION OF A POTENTIALLY FATAL DOSE OF OXYCODONE.

Full prescribing information for OxyContin is available at http://www.purduepharma.com/PRESSROOM/PI/OXYCONTIN_PI.PDF.

Purdue Pharma L.P.

CONTACT: James Heins of Purdue Pharma L.P., +1-203-588-8069

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