10:38 AM EDT, 06/13/2024 (MT Newswires) -- Collegium Pharmaceutical ( COLL ) said Thursday that the US Food and Drug Administration granted pediatric exclusivity for Nucynta and Nucynta ER, extending the exclusivity period for the Nucynta franchise by six months.
The exclusivity of the Nucynta franchise has been extended to Jan. 3, 2027 while that of Nucynta ER will end on Dec. 27, 2025, according to the company.
Nucynta is approved for the management of acute pain in adults as well as children 6 years and older while Nucynta ER is approved to treat severe and persistent pain in adults, Collegium said.