FDA Grants Tentative Approval to Collegium’s Xtampza ER

The FDA has granted tentative approval to Collegium Pharmaceutical’s NDA for Xtampza ER to manage pain severe enough to require daily, long-term opioid treatment and for which alternative treatment options are inadequate.

While the FDA determined the drug met all of the required quality, safety and efficacy standards for approval, Xtampza ER (oxycodone) is subject to an automatic stay of up to 30 months due to patent litigation filed by Purdue Pharma.

Purdue claims the drug infringes three Orange Book-listed patents that the U.S. District Court for the Southern District of New York recently found invalid, and are currently under appeal. Final approval can be achieved if Collegium receives a court order that the listed patents are invalid or not infringed, or if the litigation is settled before the expiration of the 30-month period.