
Core Viewpoint - Soleno Therapeutics has announced the U.S. commercial availability of VYKAT™ XR, the first FDA-approved treatment for hyperphagia in patients with Prader-Willi syndrome (PWS) aged four years and older, following its approval on March 26, 2025 [1][3]. Group 1: Product Launch and Availability - VYKAT XR has been delivered to the first patients with PWS who have been prescribed the medication [2]. - The company has established a comprehensive support program, Soleno ONE™, to assist patients, caregivers, and healthcare providers in accessing VYKAT XR [3]. Group 2: Company Background and Product Information - Soleno Therapeutics focuses on developing novel therapeutics for rare diseases, with VYKAT XR being its first commercial product [11]. - VYKAT XR is indicated for treating hyperphagia in adults and pediatric patients aged four years and older with PWS [6]. Group 3: Understanding Prader-Willi Syndrome - PWS is a rare genetic neurodevelopmental disorder occurring in approximately one in every 15,000 live births, characterized by hyperphagia, which can lead to severe health complications and diminished quality of life [5].