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 Viewpoint - The submission of the New Drug Application (NDA) for DCCR (diazoxide choline) extended-release tablets to the FDA represents a significant advancement for Soleno Therapeutics and individuals with Prader-Willi syndrome (PWS) [1][6]. Group 1: Company Overview - Soleno Therapeutics, Inc. is a clinical-stage biopharmaceutical company focused on developing novel therapeutics for rare diseases [10]. - The company has submitted an NDA for DCCR, which is a once-daily oral tablet aimed at treating PWS [10]. Group 2: Product Information - DCCR is designed to treat hyperphagia, a life-threatening symptom of PWS, and has received Breakthrough and Fast Track Designations in the U.S., as well as Orphan Drug Designation for PWS in both the U.S. and E.U. [7][9]. - The development program for DCCR is supported by data from five completed Phase 1 clinical studies and three completed Phase 2 clinical studies, including one involving individuals with PWS [9]. Group 3: Market Context - PWS occurs in approximately 1 in every 15,000 live births, with hyperphagia being the hallmark symptom that severely impacts the quality of life for affected individuals and their families [8]. - There are currently no approved therapies to address the hyperphagia, metabolic, cognitive, or behavioral aspects of PWS [8].