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# Soleno Therapeutics NDA for Prader-Willi Drug
- URL: https://www.fdaweb.com/soleno-therapeutics-nda-for-prader-willi-drug/
- Published: 2024-08-28T12:00:00.000Z
- Updated: 2026-09-14T14:39:50.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5157671

FDA has accepted for priority review a Soleno Therapeutics NDA for DCCR (diazoxide choline) for treating Prader-Willi syndrome (PWS) in individuals aged four years and older who have hyperphagia. The agency has set a 12/27 user fee review action target date.

The company says the hallmark symptom of the disorder is hyperphagia, a chronic and life-threatening condition characterized by feelings of intense, persistent hunger, food pre-occupation, and an extreme drive to seek and consume food, which can severely diminish the quality of life for affected individuals. “Additional characteristics of PWS include behavioral problems, cognitive disabilities, low muscle tone, short stature (when not treated with growth hormone), the accumulation of excess body fat, developmental delays, and incomplete sexual development,” it says.

The submission is based on Phase 3 data that “showed promise” in addressing hyperphagia, as well as several other symptoms such as aggressive/destructive behaviors, fat mass and other metabolic parameters, the company says.