Collegium Obtains Six Month Extension of U.S. Pediatric Exclusivity for Nucynta Franchise

FDA Approval and Exclusivity - FDA granted pediatric exclusivity for Nucynta and Nucynta ER, extending U.S. exclusivity for Nucynta to January 3, 2027, and for Nucynta ER to December 27, 2025 [3] - The pediatric exclusivity enhances the value of the Nucynta franchise and strengthens the company's near-term outlook [1] Product Indications and Usage - Nucynta ER is approved for managing severe and persistent pain in adults requiring extended opioid treatment, including neuropathic pain associated with diabetic peripheral neuropathy [1] - Nucynta tablets are indicated for acute pain in adults and pediatric patients aged six years and older with a body weight of at least 40 kg [18][22] Market and Commercialization - The company focuses on improving the lives of people with serious medical conditions through its diversified specialty pharmaceutical products [4] - The extension of exclusivity for Nucynta and Nucynta ER provides a competitive advantage in the U.S. market [3] Regulatory and Safety Information - Nucynta ER and Nucynta tablets carry significant risks, including addiction, abuse, misuse, and life-threatening respiratory depression [17][32] - Healthcare providers are encouraged to complete REMS-compliant education programs to ensure safe use of Nucynta products [17] Forward-Looking Statements - The company's forward-looking statements include expectations regarding market opportunities, financial performance, and product commercialization [11][12] - Risks such as regulatory challenges, market competition, and intellectual property protection could impact future performance [11]