Collegium Pharmaceutical, Inc. (Nasdaq:COLL) today announced that the U.S. Food and Drug Administration (FDA) has advised Collegium that it will not be able to complete its review of the New Drug Application (NDA) for Xtampza™ ER (oxycodone) extended-release capsules by the Prescription Drug User Fee Act (PDUFA) action date of October 12, 2015.
“We are confident in the Xtampza ER program and our NDA submission. We continue to work closely with the FDA as they complete their review,” said Michael Heffernan, Collegium’s Chairman and CEO.
“We look forward to bringing Xtampza ER to market as a potential novel treatment option for patients in need of chronic pain therapy.”
About Xtampza ER
Collegium’s lead product candidate, Xtampza™ ER, is an abuse-deterrent, extended-release, oral formulation of oxycodone in development 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 active ingredient in Xtampza is oxycodone, which is approved by the FDA and other regulators around the world in a number of both immediate-release and extended-release drug products. Collegium developed Xtampza using its proprietary DETERx® abuse-deterrent technology to
address common methods of abuse, including chewing, crushing and/or dissolving, and then taking it orally or snorting or injecting.
About Collegium Pharmaceutical, Inc.
Collegium is a specialty pharmaceutical company focused on developing a portfolio of products that incorporate its patent-protected DETERx® technology platform for the treatment of chronic pain and other diseases. The DETERx oral drug delivery technology is designed to provide extended-release delivery, unique abuse-deterrent properties, and flexible dose administration options.