January 24 ,2022 -- PWSA| USA is sharing the most recent news released on the status of Soleno Therapeutics' drug DCCR (diazoxide choline) for the treatment of Prader-Willi syndrome. Soleno announced today that it has received the official minutes from a December 2021 meeting with the FDA's Division of Psychiatry. This meeting was a follow up to an October 2021 meeting where Soleno sought out the FDA's support of a New Drug Application (NDA) for DCCR. In this October meeting with the FDA, Soleno shared data from their Study C602.
Based on the FDA's official meeting minutes, which was sent to Soleno on January 20, 2022, they have asked the drug company to continue with their testing and provide further data from those currently enrolled in Study C602.
"We appreciate the constructive dialogue with the FDA and the potential to obtain additional controlled clinical data from participants already enrolled in C602. This approach would significantly reduce the time and cost to obtain the necessary data," said Anish Bhatnagar, M.D., Chief Executive Officer of Soleno Therapeutics. "Importantly, we are continuing our preparations for an NDA submission for DCCR while the additional data are being collected."
PWSA | USA will continue to provide updates on the progress of DCCR and the information shared by Soleno and the FDA.