Soleno Therapeutics Announces Peer-Reviewed JCEM Publication Highlighting VYKAT XR Withdrawal Period Study In Prader-Willi Syndrome

Soleno Therapeutics, Inc. (Soleno) (NASDAQ:SLNO), a biopharmaceutical company developing novel therapeutics for the treatment of rare diseases, today announced a publication in the peer-reviewed Journal of Clinical Endocrinology and Metabolism (JCEM). The paper, titled, "Diazoxide Choline Extended-Release Tablets in Prader-Willi Syndrome: A Randomized, Double-Blind, Placebo-Controlled, Withdrawal Period Study," details results from the 16-week randomized withdrawal study (C602-RWP) of VYKAT™ XR (also known as diazoxide choline extended-release tablets, or DCCR) in children and adults 4 years and older with hyperphagia in Prader-Willi syndrome (PWS). The paper can be accessed online here.

The randomized withdrawal period study was a key part of the comprehensive Phase 3 clinical program that established the efficacy and safety of VYKAT XR and supported its approval by the U.S. Food and Drug Administration (FDA) as the first and only treatment for hyperphagia in people living with PWS. This clinical program included 127 participants with over 400 patient years of drug exposure, including individuals with nearly six years of continuous treatment.