Collegium's Xtampza ER gets FDA nod

Collegium Pharmaceutical Inc. (NASDAQ:COLL) gained $2.52 (14%) to $20.95 in early after-hours trading Tuesday after it said FDA approved Xtampza ER oxycodone extended-release to manage pain severe enough to require daily, around-the-clock, long-term opioid treatment and for which alternative treatment options are inadequate.

In November, FDA granted tentative approval to the extended-release oral oxycodone formulated with DETERx tamper resistance technology, pending the resolution of litigation against Collegium by Purdue Pharma L.P. (Stamford, Conn.). In February, Collegium said the District Court of Massachusetts ruled in its favor in the patent infringement lawsuit (see BioCentury Extra, Nov. 9, 2015). ...