FDA accepts NDA re-filing of Remoxy (extended release oxycodone) to treat severe pain.- Pain Therapeutics

DURECT Corporation announced its licensee, Pain Therapeutics, has been informed by the FDA that the New Drug Application (NDA) for Remoxy, an abuse-deterrent formulation of extended-release oxycodone (CII) capsules, is sufficiently complete to permit a substantive review, and that September 25, 2016 is the target action date under the Prescription Drug User Fee Act (PDUFA).

Comment:Remoxy, an investigational drug, is a unique long-acting oral formulation of oxycodone intended to manage pain severe enough to require daily, around-the-clock, long-term opioid treatment and for which alternative treatment options are inadequate.Based on DURECT's ORADUR technology, which is covered by issued patents and pending patent applications. Remoxy is designed to discourage common methods of tampering associated with prescription opioid analgesic misuse and abuse.

Comment: Remoxy has been developed 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.