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Soleno Therapeutics Provides Regulatory Update on DCCR for the Treatment of Prader-Willi Syndrome
FDA acknowledges that data from a randomized withdrawal period of Study C602 have the potential to support an NDA submission REDWOOD CITY, Calif., July 20,
About this update from Soleno Therapeutics, Inc.
[{"type":"text","content":"FDA acknowledges that data from a randomized withdrawal period of Study C602 have the potential to support an NDA submission\nREDWOOD CITY, Calif., July 20, 2022 (GLOBE NEWSWIRE) -- 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 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 this year, 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. “We are pleased to continue our constructive dialogue with the FDA. This randomized withdrawal period may enable us to obtain the data needed to support an NDA in an efficient and timely manner,” said Anish Bhatnagar, M.D., Chief Executive Officer of Soleno Therapeutics. “We appreciate the continued support of the participants and families in Study C602 in helping move the DCCR development program forward.” 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. About PWSThe Prader-Willi Syndrome Association USA estimates that PWS occurs in one in every 15,000 live births in the U.S. The hallmark symptom of this disorder is hyperphagia, a chronic feeling of insatiable hunger that severely diminishes ...