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.