Pain Therapeutics re-files at FDA Remoxy an abuse-deterrent formulation of extended-release oxycodone for long-term opioid treatment of pain.

Pain Therapeutics, Inc. announced that it has resubmitted to the FDA a New Drug Application (NDA) for Remoxy, an abuse-deterrent formulation of extended-release oxycodone (CII) capsules. Pain Therapeutics expects to be notified by the FDA of a Prescription Drug User Fee Act (PDUFA) action date within 30 days.

The original Remoxy NDA has a Priority Review designation. Remoxy is a proprietary drug developed and owned by Pain Therapeutics. The drug candidate's proposed indication is for "the management of pain severe enough to require daily, around-the-clock, long-term opioid treatment and for which alternative treatment options are inadequate". Pain Therapeutics specifically developed Remoxy to make oxycodone difficult to abuse yet provide 12 hours of steady pain relief when used appropriately by patients. In particular, Remoxy's thick, sticky, high-viscosity formulation may deter unapproved routes of drug administration, such as injection, snorting or smoking. Pain Therapeutics owns exclusive, worldwide rights to Remoxy.