Soleno Therapeutics Gains FDA Support for DCCR Trial Design in Prader-Willi Syndrome
• Soleno Therapeutics received positive feedback from the FDA regarding its Phase III trial design for Diazoxide Choline Controlled-Release (DCCR) in Prader-Willi Syndrome (PWS).
• The FDA supports using change in hyperphagia score as the primary endpoint, without requiring a change in weight, compared to placebo.
• The FDA agreed to a shorter 3-4 month randomized, double-blind, placebo-controlled study, with long-term safety data collected separately.
• Soleno plans to finalize the Phase III trial design, aiming to enroll approximately 100 patients, with study initiation expected by the end of 2017.
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