FDA to Review Remoxy NDA for Pain Management
Durect and its licensee, Pain Therapeutics, announced that the Food and Drug Administration (FDA) has accepted for review the New Drug Application (NDA) for Remoxy (extended-release oxycodone). Remoxy is intended 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.
The FDA has set a Prescription Drug User Fee Act (PDUFA) target action date of September 25, 2016 to make a decision on the NDA.
Remoxy is an investigational, oral, long-acting formulation of oxycodone (CII). It utilizes Durect's Oradur technology which introduces abuse-deterrent properties designed to discourage common methods of tampering associated with prescription opioid analgesic misuse and abuse.
For more information visit Durect.com.