Collegium Pharmaceutical, Inc. announced that the U.S. Food and Drug Administration (FDA) has granted pediatric exclusivity for Nucynta®? and Nucynta®? ER ("the Nucynta Franchise").

In 2023, FDA granted New Patient Population exclusivity for Nucynt a in pediatrics, extending the period of U.S. exclusivity from June 27, 2025, to July 3, 2026. FDA's 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 ER is currently approved in the U.S. for the management of severe and persistent pain in adults that requires an extended treatment period with a daily opioid analgesic, in light of the known risks associated with opioid analgesic use, and for which alternative treatment options are inadequate, and severe and persistent neuropathic pain associated with diabetic peripheral neuropathy (DPN) in adults that requires an extendedtreatment period with a daily opioid opioid analgesic and for which alternative treatment options is inadequate.