Pain Therapeutics, Inc has received a Complete Response Letter from the US Food and Drug Administration (FDA) for its New Drug Application (NDA) 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 of Remoxy. The FDA has not requested or recommended additional clinical efficacy studies prior to approval.
Pain Therapeutics, its commercial partner, King Pharmaceuticals, Inc and outside technical advisors are evaluating the FDA Complete Response Letter, will discuss the Letter with the FDA, and will provide an update when appropriate.
Pain Therapeutics and King Pharmaceuticals remain diligently committed to their strategic alliance to develop and commercialize Remoxy and other abuse-resistant pain medications.
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 misuse and abuse.