Collegium Pharma (COLL) Announces Submission of Xtampza ER SNDA to U.S. FDA

October 5, 2016 7:06 AM EDT
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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 OxyContin® (oxycodone hydrochloride extended-release tablets) and a control (oxycodone hydrochloride immediate-release)

The results for Xtampza ER, consistent with the data included in Xtampza ER prescribing information, demonstrated that crushing Xtampza ER prior to oral administration did not significantly affect its drug release profile. The results for OxyContin replicated the results from Collegium’s previously published clinical study demonstrating that, in contrast to Xtampza ER, crushing OxyContin accelerated its drug release profile making it bioequivalent to immediate-release oxycodone. The sNDA includes an amendment to the Xtampza ER prescribing information to include comparative pharmacokinetic data for intact and crushed OxyContin alongside the data for intact and crushed Xtampza ER.

Although Xtampza ER has abuse-deterrent properties, abuse by injection and by the nasal route of administration, as well as by the oral route is still possible.

About Collegium Pharmaceutical, Inc.

Collegium is a specialty pharmaceutical company focused on developing a portfolio of products that incorporate its proprietary DETERx® technology platform for the treatment of chronic pain and other diseases. The DETERx technology platform is designed to provide extended-release delivery, unique abuse-deterrent properties, and flexible dose administration options.



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