Collegium Pharmaceutical, Inc. announced that the United States Food and Drug Administration (FDA) has granted tentative approval to the Company's New Drug Application (NDA) for Xtampza™ ER (oxycodone) extended-release capsules 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.
With a tentative approval, the FDA has determined that Xtampza ER meets all of the required quality, safety and efficacy standards for approval but it is subject to an automatic stay of up to 30 months as a result of patent litigation filed by Purdue Pharma, L.P (Purdue) in March 2015. Purdue claims that Xtampza ER infringes three Orange Book listed patents that were recently found to be invalid by the United States District Court for the Southern District of New York and are currently under appeal. If Collegium receives a court order that the listed patents are invalid or not infringed, or if Collegium settles the Purdue litigation prior to the expiration of the 30-month period, the FDA can then provide final approval of Xtampza ER, at which point the product can be marketed.
"We are very pleased that the FDA has granted tentative approval for Xtampza ER. The FDA has recognized that Xtampza ER has abuse-deterrent properties consistent with FDA's final guidance titled, Guidance for Industry: Abuse-Deterrent Opioids - Evaluation and Labeling," stated Michael Heffernan, Collegium's Chairman and CEO. "We remain confident that Xtampza ER does not infringe the three patents that Purdue has asserted against us. We intend to vigorously defend ourselves against these claims."
Dr. Bill McCarberg, a founding member of the Chronic Pain Management Program at Kaiser Permanente and President of the Western Pain Society, stated,"Upon final approval, Xtampza ER may provide a unique extended-release, abuse-deterrent treatment option for the large unmet need of patients with chronic pain and dysphagia. Patients or their caregivers often inadvertently crush their medication to facilitate swallowing, which is dangerous with currently marketed ER products. In addition, abusers will seek to crush or chew ER opioids to rapidly release the drug from the formulation in order to achieve a 'high'. Xtampza ER could be beneficial in addressing both of these significant issues."
