12.09.2015 05:54:59
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FDA Panel Gives Thumbs-Up To Collegium's Abuse-deterrent Analgesic
(RTTNews) - An FDA panel, which reviewed Collegium Pharmaceutical Inc.'s (COLL) New drug Application for Xtampza ER, an abuse-deterrent analgesic for chronic pain, on Friday, has unanimously recommended approval of the drug.
Xtampza ER is an abuse-deterrent, extended-release, oral formulation of oxycodone for the treatment of chronic pain in patients who have difficulty swallowing pills.
The FDA's final decision on Xtampza ER is set for October 12, 2015. The FDA usually follows the recommendations of its advisory panels, although it is not required to do so.
Collegium went public on the Nasdaq on May 7, 2015, priced at $12.00 per share. The stock, which closed Thursday's trading at $13.45, was placed in a trading halt on Friday.
Keep an eye on COLL to see how the stock plays out on Monday.
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