Collegium Pharma (COLL) Submits Xtampza ER NDS to Health Canada

October 3, 2016 9:04 AM EDT
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Collegium Pharmaceutical, Inc. (Nasdaq: COLL) announced the submission of a New Drug Submission (NDS) to Health Canada seeking marketing approval of 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.

“Submitting the NDS in Canada for Xtampza ER is an important milestone for Collegium and a critical step towards our goal of expanding the footprint of Xtampza ER beyond the United States,” said Michael Heffernan, Chief Executive Officer of Collegium. “Xtampza ER is intended to offer abuse-deterrent properties and also allow for flexible dosing administration (e.g. sprinkling on food, administration through feeding tube) for patients with chronic pain with difficulty swallowing.”

Canada ranks second to the United States in per capita prescription opioid use worldwide.1 However, abuse of prescription opioids is considered an important public health and safety issue by Health Canada and other stakeholders2. In March 2016, in response to the opioid abuse epidemic, Health Canada published guidance for abuse-deterrent formulations in an effort to decrease incidence of opioid abuse and the subsequent harm including addiction, overdose or death.3

Xtampza ER utilizes Collegium’s proprietary DETERx® technology platform, providing adequate pain control while maintaining its extended-release profile even if subjected to common methods of manipulation, including chewing and crushing the product prior to administration. In addition, Xtampza ER supports the administration of the product by sprinkling the capsule contents on soft foods or into a cup, and then directly into the mouth, or through a gastrostomy or nasogastric feeding tube.

Abuse of Xtampza ER by injection and by the nasal route of administration, as well as by the oral route is still possible.

About Xtampza ER

Xtampza ER is Collegium’s first product utilizing the DETERx technology platform. Xtampza ER is an abuse-deterrent, extended-release, oral formulation of oxycodone approved by the FDA 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.



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