FDA Approves First-Ever Hyperphagia Treatment for PWS

After years of dedicated advocacy by the Prader-Willi Syndrome Association USA and groundbreaking research, Soleno Therapeutics has announced that the U.S. Food and Drug Administration (FDA) has approved VYKAT™ XR (diazoxide choline), formerly known as DCCR, as the first-ever treatment for hyperphagia in individuals with Prader-Willi syndrome (PWS). This milestone marks a historic moment for the PWS community, providing hope for patients and families affected by the condition.

Hyperphagia, an overwhelming and persistent hunger, is one of the most challenging symptoms of PWS, often leading to severe health complications. The approval of VYKAT XR offers a long-awaited therapeutic option, following extensive clinical trials demonstrating its potential to manage this debilitating symptom.

"This approval is a testament to the resilience of the PWS community and the tireless efforts of advocates, researchers, and families," said Soleno Therapeutics in their official announcement.

To learn more about this milestone, watch the video announcement here

For the full press release, visit Soleno Therapeutics’ official announcement.