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Collegium Receives FDA Approval for Xtampza(TM) ER, an Analgesic with Abuse-Deterrent Properties for the Treatment of Chronic Pain

CANTON, Mass., Apr 26, 2016 (GLOBE NEWSWIRE via COMTEX) --

Collegium Pharmaceutical, Inc. COLL, -2.18% today announced that the U.S. Food and Drug Administration (FDA) approved Xtampza(TM) ER (oxycodone) extended-release (ER) capsules CII, a twice-daily, oxycodone medication 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.

Xtampza ER is Collegium's first product utilizing its proprietary DETERx [(R)] technology platform, and is designed to provide adequate pain control while maintaining its drug release profile after being subjected to common methods of manipulation including chewing and crushing the product prior to administration. The Xtampza ER label contains information supporting 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.

"The FDA approval of Xtampza ER is a major milestone for Collegium. Our DETERx technology platform was developed internally and our lead product completed an extensive battery of abuse-deterrent testing consistent with the FDA Guidance on Abuse-Deterrent Opioids. Collegium is committed to supporting responsible, appropriate prescribing for only those patients suffering from chronic pain who don't have alternative non-opioid treatment options. Xtampza ER will provide clinicians with another treatment option for these patients," said Michael Heffernan, CEO of Collegium.

Dr. Jeffrey Gudin, Director of Pain Management and Palliative Care at Englewood Hospital and Medical Center, stated, "Abuse-deterrent opioids are a critical component to fighting the widespread national epidemic of prescription opioid abuse. The FDA approval of Xtampza ER is incredibly timely as abuse and misuse of opioids is at an all-time high. Xtampza ER offers unique properties that prevent rapid release when the product is crushed or chewed. In addition to having differentiated, abuse-deterrent properties, Xtampza ER also allows for flexible dosing administration for patients with difficulty swallowing. Patients or their caregivers often inadvertently crush their medication to facilitate swallowing, which can be very dangerous with currently marketed ER products. Xtampza ER can be beneficial in addressing both intentional abuse and unintentional misuse."

Collegium plans to launch Xtampza ER in the United States in mid-2016 with five dosage strengths equivalent to 10 mg, 15 mg, 20 mg, 30 mg and 40 mg oxycodone hydrochloride.

About Collegium Pharmaceutical, Inc.

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

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