FDA advisory panels recommend approval of Xtampza ER

The US Food and Drug Administration’s Anesthetic and Analgesic Drug Products Advisory Committee and Drug Safety and Risk Management Advisory Committee on Friday voted unanimously to support the approval of Xtampza ER (oxycodone extended-release capsules).

The drug from Collegium Pharmaceutical (Nasdaq: COLL) is recommended 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, Collegium's lead product candidate, 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 (PDUFA) goal date of October 12, 2015 for completion of its review of the Xtampza ER New Drug Application.