FDA accepts Pain Therapeutics NDA resubmission for REMOXY

Jan 27 2011

Pain Therapeutics, Inc. (Nasdaq:PTIE) today announced that the U.S. Food and Drug Administration (FDA) has accepted a New Drug Application (NDA) resubmission for REMOXY^® (controlled-release oxycodone) and has classified it as a Class 2 resubmission.

With the Class 2 designation, the FDA has set a corresponding Prescription Drug User Fee Act (PDUFA) goal date of June 23, 2011.

REMOXY is a twice daily, long-acting formulation of oral oxycodone for moderate to severe pain requiring continuous, around-the-clock opioid treatment for an extended period of time. This investigational drug candidate was developed to help address the growing problem of non-medical use of prescription opioids. REMOXY is designed to provide steady, around-the-clock pain relief, while resisting common methods of tampering intended to result in the rapid release of oxycodone. REMOXY is a unique formulation of the patented ORADUR^™ technology licensed from Durect Corporation (Nasdaq:DRRX).