FDA grants pediatric exclusivity for Nucynta franchise; exclusivity extended to Jan 2027

COLLEGIUM PHARMACEUTICAL, INC

FDA granted pediatric exclusivity for Nucynta and Nucynta ER; Nucynta exclusivity now to Jan 3, 2027, Nucynta ER to Dec 27, 2025.
Pediatric exclusivity adds six months on top of previously granted New Patient Population exclusivity (granted 2023).
Collegium CMO Thomas Smith said the grant enhances the value of the Nucynta franchise and bolsters near-term outlook.
Nucynta is approved for acute pain in adults and pediatric patients 6+; Nucynta ER for severe pain and diabetic peripheral neuropathy.

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