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FDA Grants Soleno FTD

For Diazoxide Choline Controlled-Release (DCCR) for the treatment of Prader-Willi Syndrome

Soleno Therapeutics announced that the FDA has granted Fast Track designation to Diazoxide Choline Controlled-Release (DCCR) for the treatment of Prader-Willi Syndrome (PWS). Soleno is currently conducting a Phase III clinical trial of DCCR for the treatment of PWS.


Fast Track designation allows additional meetings with the FDA to discuss Soleno’s development plan to ensure the appropriate data are collected and encourages frequent written communication with the FDA regarding design of clinical trials and use of biomarkers. If certain criteria are met, the drug will be eligible for Accelerated Approval and Priority Review and also Rolling Review, which allows Soleno to submit to the FDA sections of its New Drug Application (NDA) as they are finished instead of waiting for all sections to be completed before submitting the marketing application. 

“The receipt of Fast Track designation represents a significant milestone for Soleno and our DCCR clinical development program,” said Anish Bhatnagar, M.D., chief executive officer of Soleno Therapeutics, Inc. “PWS is a devastating condition with high unmet medical need and, based on the data generated to date, we believe DCCR has the potential to address this critical treatment gap. Enrollment in our Phase III clinical trial for DCCR in PWS is ongoing at multiple sites in the U.S. 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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