Soleno Therapeutics, Inc. 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. 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. 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.