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Collegium Obtains Six Month Extension of U.S. Pediatric Exclusivity for Nucynta Franchise
STOUGHTON, Mass., June 13, 2024 (GLOBE NEWSWIRE) -- Collegium Pharmaceutical, Inc. (Nasdaq: COLL), a leading, diversified specialty pharmaceutical company
About this update from Collegium Pharmaceutical, Inc.
[{"type":"text","content":"STOUGHTON, Mass., June 13, 2024 (GLOBE NEWSWIRE) -- Collegium Pharmaceutical, Inc. (Nasdaq: COLL), a leading, diversified specialty pharmaceutical company committed to improving the lives of people living with serious medical conditions, today 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 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.” Nucynta is currently approved in the U.S. for the management of acute pain severe enough to require an opioid analgesic, in light of the known risks associated with opioid analgesic use, and for which alternative treatments are inadequate in adults and pediatric patients aged six years and older with a body weight of at least 40 kg. 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 extended treatment period with a daily opioid analgesic and for which alternative treatment options are inadequate. Please see Important Safety Information that follows below and complete product information, including the Boxed Warning, available at www.NUCYNTA.com. About Collegium Pharmaceutical, Inc. Collegium is a leading, diversified specialty pharmaceutical company committed to improving the lives of people living with serious medical conditions. Collegium’s headquar...