Soleno Therapeutics submits NDA for DCCR extended-release tablets

Soleno Therapeutics announced the submission of a New Drug Application to the U.S. Food and Drug Administration (FDA) for approval of DCCR extended-release tablets for the treatment of Prader-Willi syndrome in individuals four years and older who have hyperphagia. DCCR has Breakthrough and Fast Track Designations in the U.S., as well as Orphan Drug Designation for PWS in the U.S. and E.U. The FDA has 60 days to determine whether the NDA is accepted for review. Soleno has requested Priority Review of the NDA, which would provide a target review period of six months by the FDA after the NDA has been accepted.