Pain Therapeutics and King Pharmaceuticals Announce Final Data of Remoxy Phase III Study
pain Therapeutics, Inc. and King Pharmaceuticals, Inc. presented the final data set of a previously announced pivotal Phase III study of REMOXY®, 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. REMOXY is 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The Companies also presented results of a previously unpublished alcohol interaction study.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 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.
These data were presented at the 12th World Congress of the International Association for the Study of Pain (IASP) in Glasgow, Scotland.
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