Collegium Announces Extension of Nucynta Regulatory Exclusivity through July 2026

STOUGHTON, Mass., Aug. 24, 2023 (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 New Patient Population exclusivity for Nucynta, an immediate release formulation of tapentadol. This grant extends the period of U.S. exclusivity for Nucynta from June 27, 2025 to July 3, 2026.

The exclusivity determination is based on data from pediatric trials which were submitted in response to the FDA's Pediatric Written Request to evaluate the use of Nucynta as a treatment for pain in pediatric patients aged 6 years and older.

Nucynta is currently approved in the U.S. for the management of acute pain severe enough to require an opioid analgesic and for which alternative treatments are inadequate in adults and pediatric patients aged 6 years and older with a body weight of at least 40kg.

“We believe that this grant of additional exclusivity recognizes the importance of Nucynta in the treatment of acute, severe pain,” said Thomas Smith, M.D., Collegium’s Chief Medical Officer. “We remain committed to the Nucynta Franchise, including through continued pursuit of a pediatric extension which would extend exclusivity of the entire Nucynta Franchise an additional six months, to December 2025 for Nucynta ER and January 2027 for Nucynta.”

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 headquarters are located in Stoughton, Massachusetts. For more information, please visit the Company’s website at www.collegiumpharma.com.

NUCYNTA (tapentadol) INDICATIONS AND USAGE

NUCYNTA (tapentadol) tablets are:

• A strong prescription pain medicine that contains an opioid (narcotic) that is used to manage short term (acute) pain in adults and children 6 years of age and older who weigh at least 88 pounds (40 kg), when other pain treatments such as non-opioid pain medicines do not treat your pain well enough or you cannot tolerate them.
• An opioid pain medicine that can put you at risk for overdose and death. Even if you take your dose correctly as prescribed, you are at risk for opioid addiction, abuse, and misuse