Collegium Pharmaceuticals, Inc. (NASDAQ: COLL) has announced that the U.S. Food and Drug Administration (FDA) has granted pediatric exclusivity for the Nucynta® and Nucynta® ER, extending the period of U.S. exclusivity. In 2023, the FDA granted new patient population exclusivity for Nucynta in pediatrics, extending the period of U.S. exclusivity from June 27, 2025, to July 3, 2026. The recent grant of pediatric exclusivity now extends exclusivity of the Nucynta franchise an additional six months, to January 3, 2027, for Nucynta and December 27, 2025, for Nucynta ER.
Nucynta is currently approved in the U.S. for the management of acute pain severe enough to require an opioid analgesic, in adults and pediatric patients aged six years and older with a body weight of at least 40 kg. Meanwhile, Nucynta ER is approved for the management of severe and persistent pain in adults that requires an extended treatment period with a daily opioid analgesic, and for severe and persistent neuropathic pain associated with diabetic peripheral neuropathy (DPN) in adults that requires an extended treatment period with a daily opioid analgesic.
The company's Chief Medical Officer, Thomas Smith, M.D., expressed satisfaction with the FDA’s grant of pediatric exclusivity, emphasizing that it enhances the value of the Nucynta franchise and bolsters the company's near-term outlook.
The extension of pediatric exclusivity for the Nucynta franchise is significant for Collegium Pharmaceuticals, Inc. as it will likely impact the company's revenue and market position. As a result of these announcements, the company's shares have moved -0.0% on the market, and are now trading at a price of $31.87. For the full picture, make sure to review Collegium Pharmaceutical's 8-K report.
