FDA says "no" to Pain Thera's Remoxy in its present form

Pain Therapeutics has received a Complete Response Letter from the US Food and Drug Administration for its New Drug Application for Remoxy, an abuse-resistant, controlled-release form of oxycodone. Based on its review, the FDA has determined that the NDA is not approved in its present form. The FDA believes additional non-clinical data will be required to support the approval, but has not requested or recommended further clinical efficacy studies prior to approval.

Pain Therapeutics and its commercial partner, King Pharmaceuticals, along with outside technical advisors are evaluating the FDA Letter, which they will discuss with the agency and provide an update when appropriate.

The two companies say they remain committed to their strategic alliance to develop and commercialize Remoxy, licensed from Durect Corp, and other abuse-resistant pain medications.