Collegium Pharmaceutical, Inc. 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 Nucynt a 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 old with a body weight of at least 40kg. Life-Threatening Respiratory Depression: Serious, life-threatening, or fatal respiratory depression may occur with use of NUCYNTA tablets, especially during initiation of NUCYNTA tablets or following a dose increase. To reduce the risk of respiratory depression, proper dosing and titration of NUCYNTA tablets are essential.

Accidental Ingestion: Accidental ingestion of even one dose of NUCYNTA tablet, especially by children, can result in a fatal overdose of tapentadol. R risks From Concomitant Use With Benzodiazepines or Other CNS Depressants: Concomitant use of opioids with benzodiazepines or other central nervous system (CNS) depressants, including alcohol, may result in profound sedation, respiratory depression, coma, and death. Reserve concomitant prescribing of NUCYNTA tablets and benzodiazepines or other CNS depressants for use in patients for whom alternative treatment options are inadequate.

Neonatal Opioid Withdrawal Syndrome: If opioid use is required for an extended period of time in a pregnant woman, advise the patient of the risk of Neonatal Opioid With drawal Syndrome which may be life threatening if not recognized and treated. Ensure that management by neonatology experts will be available at delivery. Opioid Analgesic Risk Evaluation and Mitigation Strategy (REMS) Healthcare providers are strongly encouraged to complete a REMS-compliant education program and to counsel patients and caregivers on serious risks, safe use, and the importance of reading the Medication Guide with each prescription.

important information about NUCYNTA tablets: Get emergency help or call 911 right away if take too much NUCYNTA (overdose) tablets. When first start taking NUCYNTA tablets, when dose is changed, or if take too much (overdose), serious or life-threatening breathing problems that can lead to death may occur. These are not all of the possible side effects of NUCYNTA tablets.

Call doctor for medical advice about side effects. One may report side effects to FDA at 1-800-FDA-1088. For more information, go go to FDA at 1-800 -FDA-1088.