Soleno Therapeutics receives BTD from U.S. FDA for diazoxide choline

Soleno Therapeutics announced that the U.S. Food and Drug Administration, FDA, has granted Breakthrough Therapy Designation, BTD, to diazoxide choline for the treatment of adults and children ages 4 years and older with genetically confirmed Prader-Willi syndrome who have hyperphagia. The designation reflects the Agency’s determination that, based on an assessment of the preliminary data from the Phase 3 clinical development program, diazoxide choline may demonstrate substantial improvement on a clinically significant endpoint over available therapies.