Soleno Therapeutics (NASDAQ: SLNO) shares are up 11% on news that the company has received the minutes from a scientific advice meeting from the U.S. Food and Drug Administration (FDA) regarding Diazoxide Choline Controlled-Release (DCCR) for the treatment of Prader-Willi syndrome (PWS). The company previously submitted data from a phase II study of DCCR in PWS patients, as well as data from other studies conducted with DCCR. The company agreed with the FDA’s suggestion that the duration of the study should be shorter and that DCCR safety information could be obtained in a long-term, safety extension study. Soleno said it plans to finalize the design of a phase III, randomized, double-blind placebo-controlled study that will treat approximately 100 patients. Subject to final agreement by the FDA, the study is anticipated to start at the end of 2017. “We remain committed to the development of DCCR, which, if approved, could provide the desperately needed treatment for this life-threatening condition. Based on the clinical data generated to date, we believe DCCR has the potential to be a safe and effective treatment for PWS patients, and look forward to initiating this Phase III trial before the end of 2017,” Soleno CEO Anish Bhatnagar, M.D. stated in the news release.
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About Soleno Therapeutics, Inc.
Soleno Therapeutics, Inc. is focused on the development and commercialization of novel therapeutics for the treatment of rare diseases. The company is currently advancing its lead candidate, DCCR, a once-daily oral tablet for the treatment of PWS, into a phase III clinical development program at the end of 2017. Soleno, through its wholly owned subsidiary, Capnia, Inc., continues to market Capnia’s innovative medical devices, including the CoSense® End-Tidal Carbon Monoxide (ETCO) monitor, which measures ETCO and is used by hospitals to detect hemolysis in newborns, and the NeoForce portfolio of neonatal pulmonary resuscitation solutions. It is expected that these products will be monetized and will not be a focus for the company in the long term. For more information, please visit www.soleno.life.
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