Benzinga | Jan 24, 2022 08:03AM EST

Soleno Therapeutics Provides Regulatory Update On DCCR For The Treatment Of Prader-Willi Syndrome

Soleno Therapeutics, Inc. (Soleno or the Company) (NASDAQ:SLNO), a clinical-stage biopharmaceutical company developing novel therapeutics for the treatment of rare diseases, today provided an update following recent interactions with the U.S. Food and Drug Administration (FDA) regarding the development of once-daily DCCR (diazoxide choline) extended-release tablets for the treatment of Prader-Willi syndrome (PWS).

On January 20, 2022, the Company received official meeting minutes from the December 21, 2021, Type C meeting with the FDA's Division of Psychiatry. The purpose of the meeting was to discuss the adequacy of the data submitted by Soleno to the FDA in October 2021 to support a potential New Drug Application (NDA) submission for DCCR for the treatment of PWS, as well as possible ways to generate additional controlled clinical data. The FDA indicated they were receptive to a study design involving participants currently enrolled in Study C602, the Company's ongoing open-label extension study to generate the additional control data necessary to support an NDA. The Company expects to submit a study proposal shortly and, if acceptable, intends to initiate the study thereafter.

"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."

Study C602 is an open-label extension study comprised of patients who completed DESTINY PWS, an international, multi-center, randomized, double-blind, placebo-controlled study of DCCR.