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FDA Advisory Committee will review Pain Therapeutics REMOXY New Drug Application

 

Clinical courses

Pain Therapeutics, Inc. announced that an Advisory Committee of the U.S. Food and Drug Administration (FDA) will review the REMOXY® New Drug Application (NDA), tentatively scheduled for Friday, August 5, 2016.  This is intended to be a joint meeting of the FDA's Anesthetic and Analgesic Drug Products Advisory Committee and Drug Safety and Risk Management Advisory Committee.

REMOXY ER is a proprietary, abuse-deterrent, extended-release oral formulation oxycodone (CII).  The proposed indication for this drug candidate 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."

"This could be a prime opportunity to showcase the abuse-deterrence and other properties of our lead drug candidate, REMOXY," said Remi Barbier, President & CEO of Pain Therapeutics.  "We look forward to sharing our data with the FDA, Committee members and the general public."

FDA also advised us that the Prescription Drug User Fee Act (PDUFA) date for the REMOXY NDA, September 25, 2016, is unchanged.

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