Collegium obtains six month extension of U.S. pediatric exclusivity for Nucynta

Collegium Pharmaceutical announced that the U.S. Food and Drug Administration, FDA, has granted pediatric exclusivity for Nucynta and Nucynta ER. In 2023, 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. 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. “We are pleased with FDA’s grant of pediatric exclusivity for the Nucynta Franchise,” said Thomas Smith, M.D., Collegium’s Chief Medical Officer. “This grant of pediatric exclusivity enhances the value of the Nucynta franchise and bolsters our near-term outlook. Collegium is proud to lead with science in support of people living with serious medical conditions and the communities we serve.”