The Foundation For Prader-Willi Research

FDA Approves First Treatment for Hyperphagia in Prader-Willi Syndrome

- The FDA has approved VYKAT XR (diazoxide choline) as the first therapy specifically targeting hyperphagia in Prader-Willi syndrome, offering new hope to patients and families affected by this rare genetic disorder. - Clinical trials demonstrated VYKAT XR's efficacy through a Phase 3 randomized withdrawal study, where patients switching to placebo showed significant worsening of hyperphagia compared to those remaining on the medication. - Soleno Therapeutics expects to make VYKAT XR available in the US by April 2025, supported by the Soleno One patient support program to facilitate access to this breakthrough treatment.