Soleno Therapeutics Announces Publication of Results from Pivotal Study of VYKAT™ XR in the Journal of Clinical Endocrinology and Metabolism

Core Insights - Soleno Therapeutics, Inc. announced the publication of a study in the Journal of Clinical Endocrinology and Metabolism, detailing the efficacy and safety of VYKAT™ XR for treating hyperphagia in Prader-Willi syndrome (PWS) [1][2][3] Study Details - The study was a 16-week randomized withdrawal study involving 77 participants aged 4 years and older, previously treated in Phase 3 studies [2][6] - Participants were randomized 1:1 to receive either VYKAT XR (n=38) or placebo (n=39), with the primary endpoint being the change in Hyperphagia Questionnaire for Clinical Trials (HQ-CT) total score from baseline to week 16 [6] Efficacy and Safety - The study confirmed the safety and efficacy of VYKAT XR, showing significant worsening of hyperphagia in the placebo group compared to those on VYKAT XR (P=0.0022) [6] - Secondary endpoints, including Clinical Global Impression of Severity (CGI-S) and Improvement (CGI-I), favored VYKAT XR, although they did not reach statistical significance [6] - Adverse events were similar across both treatment arms, with no serious adverse events reported in the VYKAT XR group [6] Background on Prader-Willi Syndrome - PWS is a rare genetic disorder affecting approximately 1 in 15,000 live births, characterized by hyperphagia, which can lead to severe health complications [5][7] Product Information - VYKAT XR was approved by the FDA on March 26, 2025, and is indicated for treating hyperphagia in individuals with PWS aged 4 years and older [8][13]