Collegium Gains Six-Month Extension of U.S. Pediatric Exclusivity for Nucynta

Collegium Pharmaceutical, Inc., a prominent specialty pharmaceutical company, has announced that the U.S. Food and Drug Administration (FDA) has granted pediatric exclusivity for its products Nucynta® and Nucynta® ER. This exclusivity extends the franchise’s market protection by six months, with Nucynta now protected until January 3, 2027, and Nucynta ER until December 27, 2025.

Nucynta, which is approved for managing severe acute pain in adults and children aged six and older, and Nucynta ER, which is used for long-term treatment of severe pain and diabetic peripheral neuropathy in adults, both carry significant safety concerns due to their opioid nature. The FDA’s decision follows last year's extension for pediatric patients, which pushed Nucynta's exclusivity from June 27, 2025, to July 3, 2026.

Thomas Smith, M.D., Chief Medical Officer of Collegium, expressed satisfaction with the FDA’s decision, highlighting the enhanced value and positive outlook for the Nucynta franchise. He emphasized Collegium's commitment to leading with scientific innovation to support individuals suffering from serious medical conditions.

Nucynta (tapentadol) is an opioid analgesic approved for managing severe acute pain in adults and children weighing at least 40 kg. Nucynta ER is used for adult patients requiring a prolonged treatment period with a daily opioid for severe pain and neuropathic pain associated with diabetes. Both medications are essential where alternative treatments are inadequate, but they carry significant risks including addiction, abuse, overdose, and life-threatening respiratory issues.

Key safety information for Nucynta and Nucynta ER includes:

1. Addiction, Abuse, and Misuse: Patients using Nucynta are at risk of developing opioid addiction, abuse, and misuse, potentially leading to overdose and death. Continuous assessment of each patient's risk is essential.

2. Respiratory Depression: Serious respiratory depression can occur, particularly at the start of the treatment or following an increase in dosage. Proper dosing and titration are crucial to minimize this risk.

3. Accidental Ingestion: Even a single dose of Nucynta can be fatal if ingested accidentally, particularly by children.

4. Concomitant Use with CNS Depressants: Using Nucynta with other CNS depressants like benzodiazepines or alcohol can cause severe sedation, respiratory depression, coma, and death. It should be reserved for patients when other treatment options are inadequate.

5. Neonatal Opioid Withdrawal Syndrome: Prolonged use of opioids during pregnancy can result in this syndrome, which can be life-threatening if not treated appropriately.

Patients are advised to take Nucynta strictly as prescribed, store it securely, and dispose of any unused medication properly. They should avoid alcohol and operating heavy machinery while on Nucynta due to the risk of severe drowsiness and respiratory issues.

The announcement by Collegium also included a detailed discussion on the risks and side effects associated with Nucynta and Nucynta ER, advising healthcare providers and patients to follow REMS-compliant educational programs for safe use.

Collegium Pharmaceutical, Inc., headquartered in Stoughton, Massachusetts, continues to focus on improving lives through innovative solutions for serious medical conditions. For further details on their products and safety information, patients and providers are encouraged to visit their official website.

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