Soleno Therapeutics, Inc. has submitted a New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) seeking approval for DCCR (diazoxide choline) extended-release tablets to treat Prader-Willi Syndrome (PWS) in individuals four years and older who have hyperphagia. This represents a significant milestone for Soleno and the individuals living with PWS.
DCCR has received both breakthrough and fast track designations in the U.S., as well as orphan drug designation for PWS in the U.S. and E.U. Soleno has also requested priority review of the NDA, which, if granted, would lead to a target review period of six months after acceptance.
PWS is a rare disorder occurring in one in every 15,000 live births and is characterized by symptoms such as hyperphagia, behavioral problems, cognitive disabilities, and developmental delays. There are currently no approved therapies to treat the hyperphagia/appetite, metabolic, cognitive function, or behavioral aspects of the disorder.
DCCR, a once-daily oral tablet, has shown promise in addressing hyperphagia, aggressive/destructive behaviors, fat mass, and other metabolic parameters based on data from completed phase 1 and phase 2 clinical studies. The NDA submission is supported by Soleno's phase 3 development program for DCCR.
Soleno Therapeutics, Inc. is focused on the development and commercialization of novel therapeutics for the treatment of rare diseases, with DCCR being its lead candidate. As a result of these announcements, the company's shares have moved -2.3% on the market, and are now trading at a price of $40.8. If you want to know more, read the company's complete 8-K report here.
