FDA delays approval of Collegium's Xtampza

13 October 2015

The US Food and Drug Administration has advised Collegium Pharmaceuticals (Nasdaq: COLL) that it will not be able to complete its review of the New Drug Application for Xtampza ER (oxycodone) extended-release capsules by the Prescription Drug User Fee Act (PDUFA) action date of October 12, 2015.

The decision comes as a surprised, given that the FDA’s Anesthetic and Analgesic Drug Products Advisory Committee and Drug Safety and Risk Management Advisory Committee recently voted unanimously to support the approval of Xtampza (The Pharma Letter September 12). The news sent Collegium’s shares down 2.8% to $20.09 by close of trading on Monday.

"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 chief executive, adding: "We look forward to bringing Xtampza ER to market as a potential novel treatment option for patients in need of chronic pain therapy."

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