Purdue Pharma Begins Clinical Studies of Abuse-Resistant Pain Medication

STAMFORD, Conn., Dec. 3 /PRNewswire/ -- Purdue Pharma L.P. has begun clinical studies of a new pharmaceutical product combining the opioid analgesic oxycodone in a controlled-release formulation with an opioid antagonist, naloxone. This product is designed to reduce intravenous abuse of OxyContin(R) (oxycodone HCl controlled-release) Tablets. Following completion of the clinical trials, the company will prepare a New Drug Application (NDA) for submission to the U.S. Food and Drug Administration (FDA) seeking clearance to market the medication.

"It is a complex task to develop multiple formulations with different amounts of controlled-release oxycodone combined with an antagonist," says Dr. Paul Goldenheim, Executive Vice President, Worldwide Research and Development. "While it is difficult to predict when this product might be available to patients, we are working closely with FDA and are planning to file the NDA before the end of next year."

Drug abusers have learned to defeat the time-release properties of OxyContin, by compromising the drug's delivery systems by chewing, snorting, or injecting the medication to achieve a euphoric "high." When taken as directed, the oxycodone-naloxone tablet is intended to be swallowed whole, and the small amount of naloxone should not adversely affect the patient or interfere with the analgesic effect of the oxycodone. However, if the tablet were to be crushed and injected, the naloxone would be released into the blood, where it would counteract the effect of the oxycodone - thereby diminishing the euphoria the abuser is seeking and potentially subjecting the abuser to undesirable withdrawal symptoms.

Purdue has made the development of abuse-resistant pain medications its number one research priority. To date the company has committed more than $50 million to these research efforts. In August, Purdue announced the publication of an international patent application for a new drug formulation combining an opioid pain reliever with another antagonist, naltrexone, which is intended to reduce oral and intranasal abuse.

These research efforts are part of a multifaceted plan developed by Purdue Pharma to reduce prescription drug abuse while ensuring that pain patients continue to have access to the medications they need. Other elements of the program include educational programs and materials that teach healthcare professionals about proper pain management and how to recognize and reduce prescription drug diversion, offering free tamper-resistant prescription pads to help curb prescription fraud, and an educational program alerting teenagers and pre-teens about the dangers of prescription drug abuse.

The labeling for OxyContin contains the following warnings for patients and physicians:

-- 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


-- 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 Tablets can be found online at the Purdue website at http://www.purduepharma.com/news/doc...kageInsert.pdf.

More information is available on Purdue Pharma's website at http://www.purduepharma.com.