Pain Therapeutics and King Pharmaceuticals have presented the final data set of a previously announced pivotal Phase III study of Remoxy, an investigational drug to treat chronic pain.

Approximately 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.

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. Remoxy is currently undergoing a priority review by the FDA. The companies have also presented results of a previously unpublished alcohol interaction study. In this study, human volunteers consumed Remoxy 40mg with up to eight ounces of 80? 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. Eric Carter, chief science officer of King, said: "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."