India, March 26 -- Soleno Therapeutics Inc. (SLNO) announced that the U.S. Food and Drug Administration (FDA) has approved VYKAT XR (diazoxide choline) extended-release tablets, previously referred to as DCCR, for the treatment of hyperphagia in adults and children 4 years of age and older with Prader-Willi syndrome (PWS).
Soleno expects VYKAT XR to be available in the U.S. beginning in April 2025.
Soleno has launched Soleno One, a comprehensive patient support program.
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According to the company, the FDA approval of VYKAT XR was based on an adequate and well-controlled study and safety data from the comprehensive clinical development program. Efficacy wa...