Soleno Therapeutics Announces Submission of New Drug Application to the U.S. FDA for DCCR (Diazoxide Choline) Extended-Release Tablets for the Treatment of Prader-Willi Syndrome

Core Points - Soleno Therapeutics has submitted a New Drug Application (NDA) to the FDA for DCCR (diazoxide choline) extended-release tablets aimed at treating Prader-Willi syndrome (PWS) in individuals aged four years and older who experience hyperphagia [12] - The FDA has 60 days to determine if the NDA will be accepted for review, with Soleno requesting Priority Review, which would target a six-month review period post-acceptance [2] Company Overview - Soleno Therapeutics is a clinical-stage biopharmaceutical company focused on developing novel therapeutics for rare diseases [12] - The company has established extensive patent protection for the therapeutic use of diazoxide, diazoxide choline, and DCCR in individuals with PWS [9] Product Information - DCCR is a proprietary extended-release dosage form of diazoxide choline, administered once daily, and has been used in other rare diseases but is not yet approved for PWS [9] - The development program for DCCR is supported by data from five completed Phase 1 clinical studies and three Phase 2 studies, including one involving individuals with PWS [9] Disease Context - Prader-Willi syndrome is estimated to occur in one in every 15,000 live births, characterized by hyperphagia, behavioral problems, cognitive disabilities, and other serious health issues [5] - There are currently no approved therapies to address the hyperphagia and other symptoms associated with PWS, highlighting the unmet medical need [5]