Purdue Pharma is concerned about increased reports of abuse of its pain medication, OxyContin® (controlled release oxycodone HCl) Tablets. As part of a comprehensive program of initiatives to combat this serious problem, the company has been investing tens of millions of dollars in research and development into pain relievers that are more resistant to abuse. Preliminary results appear to show some progress, according to Dr. Paul Goldenheim, Executive Vice President, Worldwide Research and Development.

"One of our recent efforts focuses on the use of an antagonist to block the effect of the opioid if it is abused," says Goldenheim. "When appropriately taken by a pain patient, the tablet is swallowed whole, and the antagonist should pass through the gastrointestinal system of a patient without significant release. Preliminary in vitro studies to date have demonstrated that the release of the antagonist from the intact dosage form is minimal (<5% of total after 36 hours). When the dosage form is tampered, such as by crushing, in vitro results show that the entire amount of antagonist is released, thus potentially causing an undesirable effect to the abuser. If these results can be confirmed in clinical studies, this will be a significant technical achievement."

Drug abusers have learned to defeat the time-release properties of certain long-acting opioid analgesics, including OxyContin, by compromising the delivery system and then snorting or injecting them to achieve a "high."

"If this tablet is abused, preliminary in vitro studies show that it behaves in a completely different way," Dr. Goldenheim continues. "Crushing the tablet to defeat its time-release properties also releases the antagonist, which blocks the effects of the opioid. Abusers will not experience euphoria and may experience the uncomfortable effects of withdrawal. We hope that knowledge of the tablet's abuse-resistant properties will deter potential drug abusers from even trying this product."

While this abuse resistant pain reliever is still in the experimental phase of development, Purdue is planning to begin clinical trials early next year.

This research effort is part of Purdue's ten-point plan to reduce prescription drug abuse, while ensuring that legitimate patients continue to have access to the medications they need. Other elements of the program include an educational program alerting teenagers and pre-teens about the dangers of prescription drug abuse, the provision of free tamper-resistant prescription pads and educational materials that help physicians and pharmacists reduce prescription drug diversion, and sponsorship of hundreds of medical education programs to educate healthcare professionals about proper pain management. The company is also working with law enforcement to curb diversion of prescription drugs through theft and fraud.

The labeling for OxyContin contains the following warning 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 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 Tablets can be found online at the Purdue web site at http://www.pharma.com/news/docs/oxyPackageInsert.pdf.

SOURCE: Purdue Pharma L.P.

WEB SITE: http://www.purduepharma.com/

WEB SITE: http://www.pharma.com/news/docs/oxyPackageInsert.pdf