Soleno breaks through with FDA nod for Prader-Willi syndrome treatment Vykat XR

Soleno Therapeutics' Vykat XR Approved for Hyperphagia in Prader-Willi Syndrome

The FDA approved Vykat XR (diazoxide choline) on March 26, 2025, as the first treatment for hyperphagia in Prader-Willi syndrome (PWS)1.

Vykat XR is approved for adults and children 4 years of age and older with PWS2.

The drug is expected to be available in the U.S. beginning in April 20252.

Vykat XR is an extended-release tablet administered once daily4.

The approval was based on a phase 3 trial showing statistically significant worsening of hyperphagia in patients switched to placebo compared to those remaining on Vykat XR2.

Common adverse reactions include hypertrichosis, edema, hyperglycemia, and rash4.

Soleno will charge $466,200 per year for Vykat XR based on the average weight of patients in clinical trials3.

PWS affects approximately 1 in every 15,000 live births in the U.S.2.

Soleno has launched a patient support program called Soleno One to assist with access and insurance processes6.

The approval represents a significant milestone for the PWS community, addressing a previously unmet medical need2.

Sources:

1. https://www.pharmexec.com/view/fda-approves-soleno-therapeutics-vykat-xr-hyperphagia-patients-prader-willi-syndrome

2. https://pmlive.com/pharma_news/fda-approves-solenos-vykat-xr-as-first-treatment-for-hyperphagia-in-prader-willi-syndrome/

3. https://www.fiercepharma.com/pharma/soleno-breaks-through-fda-nod-prader-willi-syndrome-treatment-vykat-xr

4. https://www.neurologylive.com/view/fda-approves-diazoxide-choline-extended-release-tablets-for-hyperphagia-in-prader-willi-syndrome

6. https://www.managedhealthcareexecutive.com/view/fda-approves-first-drug-for-excess-hunger-in-prader-willi-syndrome