Collegium Pharma (COLL) Announces Submission of Xtampza ER SNDA to U.S. FDA
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Collegium Submits Supplemental New Drug Submission to FDA for Xtampza® ER
October 5, 2016 7:05 AM EDTCANTON, Mass., Oct. 05, 2016 (GLOBE NEWSWIRE) -- Collegium Pharmaceutical, Inc. (Nasdaq: COLL) announced today that it has submitted a Supplemental New Drug Application (sNDA) to the U.S. Food & Drug Administration (FDA) to enhance the label for Xtampza® ER (oxycodone extended-release), an abuse-deterrent, extended-release opioid, 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 sNDA includes comparative oral pharmacokinetic data from a recently completed clinical study evaluating the effect of physical manipulation by crushing Xtampza ER compared with the abuse-deterrent version of... More
