Pain Therapeutics and King Pharmaceuticals Announce Final Data of REMOXY Phase III Study at World Pain Congress in Scotland

Business Wire, August 19, 2008

GLASGOW, Scotland -- Pain Therapeutics, Inc. (NASDAQ: PTIE) and King Pharmaceuticals, Inc. (NYSE: KG) today presented the final data set of a previously announced pivotal Phase III study of REMOXY([R]), an investigational drug to treat chronic pain. The final data confirm REMOXY provides effective around-the-clock analgesia within a patented formulation designed to resist common methods of misuse and abuse. The Companies believe this Phase III clinical study is the first to show analgesic efficacy of any twice-daily oxycodone formulation over 12 weeks in a large, well-controlled clinical study. REMOXYis currently undergoing a priority review by the U. S. Food and Drug Administration (FDA).

The Companies also presented results of a previously unpublished alcohol interaction study. In this study, human volunteers consumed REMOXY 40 mg with up to eight ounces of 80x proof alcohol to simulate the amount of alcohol consumed in a 'binge drinking' session. Results confirm that REMOXY's formulation resists dissolution in alcohol. REMOXY's lack of a 'dose-dumping' effect is intended to prevent the quick, powerful euphoric high that is sought by drug abusers.

These data were presented at the 12th World Congress of the International Association for the Study of Pain (IASP) in Glasgow, Scotland. IASP is a leading professional forum in the field of pain, consisting of 6,900 professionals involved in the treatment and research of pain.

"For public health reasons, we remain concerned about the abuse of prescription drugs and any associated addiction, overdose or deaths," said Nadav Friedmann, PhD, MD, Chief Operating and Medical Officer at Pain Therapeutics. "Our goals are to encourage physicians to treat legitimate chronic pain and to discourage recreational drug abuse. I believe this updated analysis provides further evidence of the potential for REMOXY to achieve these goals."

"The results of these studies further substantiate REMOXY(')s potential as a useful solution that may offer a new standard in chronic pain management," said Dr. Eric Carter, Chief Science Officer of King. "King is committed to developing uniquely designed medicines, such as REMOXY, that not only meet the needs of chronic pain patients but also help address the problem of prescription drug abuse and misuse, including use with alcohol, which is currently threatening our communities."

About REMOXY

REMOXY, an investigational drug, is a unique, abuse-resistant, controlled-release oxycodone for moderate-to-severe chronic pain. REMOXY's high viscosity, liquid formulation in a hard gelatin capsule is designed to resist common methods of prescription drug misuse and abuse. The New Drug Application (NDA) for REMOXYis currently undergoing a priority review by the FDA. The FDA is expected to complete its review of the REMOXY NDA in December 2008. If approved, the Companies believe REMOXY could be the first oxycodone on the market that is designed to reduce the risk of misuse and abuse.

Final Results of the REMOXY Phase III Study

412 patients with osteoarthritis participated in this pivotal study. Final data indicate that the REMOXY study achieved a statistically significant result in its primary endpoint, the decrease in pain intensity scores over the twelve week treatment period (p = 0.007), and secondary endpoints, including Quality of Analgesia (p = 0.004), Global Assessment (p = 0.007), the pain subscale of the WOMAC Osteoarthritis Index (p=0.023) and the physical component of the SF-12 Health Survey (p=0.003). No drug-related safety issues were noted in this study. As expected, common opioid-related side-effects were observed in treated patients. A copy of the poster presentation is available on Pain Therapeutics' web site at: http://www.paintrials.com/publications.html

About the Alcohol Interaction Study

This was a single-center, randomized, four-way crossover study, designed to evaluate the effects of ethanol on the rate and extent of absorption of oxycodone from REMOXY. Thirty-seven human volunteers ingested REMOXY 40mg during each of four treatment sequences that were separated by a 96-hour washout period. Study results confirm that REMOXY maintains its controlled-release mechanism when co-administered with 240mL of 4%, 20% or 40% ethanol. The co-administration of REMOXY with alcohol did not defeat REMOXY's patented controlled-release mechanism, as evidenced by plasma concentration levels. This lack of 'dose-dumping' is intended to prevent the rapid rise in oxycodone plasma levels and the resulting euphoric high that is sought by recreational drug abusers. A copy of the poster presentation is available on Pain Therapeutics' web site at http://www.paintrials.com/publications.html

About Chronic Pain

Approximately 50 million Americans suffer from chronic pain. Chronic pain can affect an individual throughout his or her life, lasting several weeks, months, or even years at a time. The onset of chronic pain may be nociceptive (caused by ongoing tissue injury), neuropathic (caused by damage to the brain, spinal cord, or peripheral nerves), or disease specific (such as osteoarthritis or cancer).