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Tentative FDA approval for Collegium's Xtampza

November 10, 2015 2:49 AM UTC

FDA granted tentative approval for Xtampza ER oxycodone from Collegium Pharmaceutical Inc. (NASDAQ:COLL). The drug is indicated for the management of pain severe enough to require daily around-the-clock opioid treatment and for which alternative treatment options are inadequate. Final approval may be delayed up to 30 months because of pending litigation against Collegium by Purdue Pharma L.P. (Stamford, Conn.).

Purdue has alleged Xtampza infringes three Orange Book-listed patents covering OxyContin oxycodone. Last year, the U.S. District Court for the Southern District of New York found the patents invalid. Purdue is appealing the decision. ...