Soleno Therapeutics, Inc. provided an update following recent communications 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). Following a recent meeting, the FDA acknowledged that data from a proposed randomized withdrawal phase of Study C602 would have the potential to address its concerns regarding the adequacy of the overall efficacy data supportive of a New Drug Application (NDA) submission for DCCR. Earlier in the year 2022, Soleno submitted a proposal to add a randomized withdrawal period to Study C602 in order to obtain additional controlled data requested by the FDA to support an NDA.

This randomized withdrawal phase would consist only of participants currently enrolled in Study C602 and not include any new patients. The Company continues to work collaboratively with the FDA to finalize specific details of the study design and plans to initiate the randomized withdrawal period in the current quarter, with top-line data expected in the first quarter of 2023. 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.

The Protocol for C602 has been amended to include a randomized withdrawal period.