10:44 AM EDT, 06/28/2024 (MT Newswires) -- Soleno Therapeutics ( SLNO ) said Friday it has submitted a new drug application to the US Food and Drug Administration for approval of DCCR (diazoxide choline) extended-release tablets for the treatment of Prader-Willi syndrome in patients aged 4 and older who have hyperphagia.

The FDA has 60 days to decide if the NDA will be reviewed, and the company has requested priority review, which would set a six-month target review period after the NDA is accepted, Soleno said.

The DCCR development program is backed by data from five phase 1 clinical studies in healthy volunteers and three phase 2 clinical studies, including one involving individuals with PWS.

The main symptom of PWS is hyperphagia, a chronic and intense hunger that severely impacts the quality of life, the company said.

Price: 43.00, Change: +1.25, Percent Change: +2.99