The Food and Drug Administration (FDA) has granted Fast Track status to diazoxide choline controlled-release tablet (DCCR; Soleno Therapeutics) for the treatment of Prader-Willi Syndrome (PWS). This extended-release, crystalline salt formulation of diazoxide is intended for once-daily administration.

Five Phase 1 and three Phase 2 clinical trials of DCCR have been completed, with one of the Phase 2 trials involving PWS patients. In this trial, the treatment showed promise in addressing symptoms of PWS, including hyperphagia. A Phase 3 trial is currently being conducted.

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“Enrollment in our Phase 3 clinical trial for DCCR in PWS is ongoing at multiple sites in the US,” said Anish Bhatnagar, MD, CEO of Soleno. “With Fast Track designation, we look forward to continued collaboration with the FDA, with the goal of delivering DCCR to patients in need as expeditiously as possible.” 

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