FDA grants Nucynta IR exclusivity extension to July 2026

COLLEGIUM PHARMACEUTICAL, INC

FDA granted New Patient Population exclusivity for Nucynta (tapentadol IR), extending U.S. exclusivity from June 27, 2025 to July 3, 2026.
Extension based on pediatric trial data submitted per FDA Pediatric Written Request for pain treatment in patients aged 6+.
Collegium continues pursuit of pediatric extension for entire Nucynta Franchise, which could add six months for Nucynta ER and IR.
Nucynta is approved for acute pain severe enough to require an opioid analgesic in adults and pediatric patients weighing ≥40 kg.

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