Collegium Announces FDA Advisory Committee Meeting for Xtampza ER, an Abuse-Deterrent Analgesic for Chronic Pain

Collegium Pharmaceutical, Inc.

today announced that a joint meeting of the Anesthetic and Analgesic Drug Products Advisory Committee and Drug Safety and Risk Management Advisory Committee of the U.S. Food and Drug Administration (FDA) is scheduled to review the Company's New Drug Application (NDA) for Xtampza™ ER (oxycodone extended-release capsules) on September 11, 2015. Xtampza ER, Collegium's lead product candidate, is an abuse-deterrent, extended-release, oral formulation of oxycodone. Xtampza ER is being developed 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 Company's NDA submission for Xtampza ER was accepted for review by the FDA on February 10, 2015. 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 NDA. "The upcoming FDA advisory committee meeting represents progress toward our goal of obtaining approval of Xtampza ER. We look forward to discussing the efficacy, safety and abuse-deterrent data included in our NDA with the Advisory Committee and will continue to work with the FDA through the review period," stated Michael Heffernan, CEO of Collegium.