FDA grants tentative approval to Xtampza ER (oxycodone extended-release) to treat severe pain- Collegium Pharmaceutical

Collegium Pharmaceutical announced that the 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 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.