FDA committee recommends aproval of Xtampza ER (oxycodone extended-release) for pain relief-Collegium Pharma

The Anesthetic and Analgesic Drug Products Advisory Committee and Drug Safety and Risk Management Advisory Committee of the FDA voted unanimously to support the approval of Xtampza ER (oxycodone extended-release capsules), from Collegium Pharma, 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.

Xtampza ER is an abuse-deterrent, extended-release, oral formulation of oxycodone, a widely prescribed opioid medication. The FDA will consider the advisory committees' recommendation as it continues its review of Xtampza ER. The FDA set a Prescription Drug User Fee Act, or PDUFA, goal date of October 12, 2015 for completion of its review of the Xtampza ER New Drug Application (NDA).

Comment: The FDA has encouraged the development of abuse-deterrent formulations, approving Purdue Pharma's Hysingla and Zohydro ER, a reformulated version of the controversial drug. Meanwhile, Pfizer is moving ahead with a rival oxycodone product, and the FDA accepted its application for the extended-release drug ALO 02 around the same time as Collegium's application.