Soleno Therapeutics Gets FDA Approval For VYKAT XR To Treat Hyperphagia In Prader-Willi Syndrome

(RTTNews) - 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.

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 was established during the 16-week randomized withdrawal study period of Study 2-RWP, a Phase 3 multi-center, randomized, double-blind, placebo-controlled trial. Individuals randomized to switch to placebo demonstrated a statistically significant worsening of hyperphagia compared with individuals who remained on VYKAT XR. Prior to participating in the randomized withdrawal period, all individuals received double-blind and/or open-label VYKAT XR for a mean duration of 3.3 years.

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