Soleno Therapeutics Announces Commercial Availability of VYKAT™ XR for Treatment of Hyperphagia in Prader-Willi Syndrome
Redwood City, CA – April 14, 2025 – Soleno Therapeutics, Inc. (Soleno), a pioneering biopharmaceutical company dedicated to developing innovative therapies for the treatment of rare diseases, is thrilled to announce the U.S. commercial availability of VYKAT™ XR (diazoxide choline) extended-release tablets. This announcement comes following the U.S. Food and Drug Administration (FDA) approval of VYKAT™ XR on March 26, 2025, for the treatment of hyperphagia in patients aged four years and older with Prader-Willi syndrome (PWS).
About Prader-Willi Syndrome
Prader-Willi Syndrome (PWS) is a rare, complex genetic disorder affecting approximately 1 in 15,000 individuals. The hallmark symptom of PWS is hyperphagia, an insatiable appetite and excessive hunger that can lead to significant weight gain and obesity, placing these patients at risk for numerous comorbidities such as cardiovascular diseases, diabetes, and respiratory problems.
Impact of VYKAT™ XR on Individuals with Prader-Willi Syndrome
The approval of VYKAT™ XR represents a significant milestone for the PWS community. This novel therapeutic approach, which uses an extended-release formulation of diazoxide choline, is designed to reduce food intake and body weight in patients with PWS. By targeting the underlying cause of hyperphagia, VYKAT™ XR offers a more effective and sustainable solution compared to current management strategies, which often rely on caloric restriction and behavioral interventions.
Global Impact of VYKAT™ XR on the World
Beyond the United States, Soleno Therapeutics is actively pursuing regulatory approvals for VYKAT™ XR in Europe, Canada, and other markets. The global impact of this therapeutic breakthrough is substantial, as it will provide a much-needed treatment option for the countless individuals and families affected by Prader-Willi Syndrome worldwide.
Conclusion
The commercial availability of VYKAT™ XR marks a pivotal moment in the treatment of Prader-Willi Syndrome. By offering a more effective and sustainable solution to the debilitating symptom of hyperphagia, Soleno Therapeutics is poised to make a significant difference in the lives of countless individuals and families affected by this rare genetic disorder. As regulatory approvals continue to roll in, the global impact of VYKAT™ XR is set to be nothing short of transformative.
- Soleno Therapeutics announces U.S. commercial availability of VYKAT™ XR for hyperphagia in Prader-Willi syndrome
- FDA approval of VYKAT™ XR on March 26, 2025
- VYKAT™ XR is an extended-release formulation of diazoxide choline
- Targets the underlying cause of hyperphagia in Prader-Willi Syndrome
- Offers a more effective and sustainable solution compared to current management strategies
- Active regulatory pursuits in Europe, Canada, and other markets
- Transformative impact on individuals and families affected by Prader-Willi Syndrome
