Advocacy Groups Oppose Additional Trial for DCCR

Advocacy Groups Oppose Additional Trial for DCCR

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Advocacy Groups Oppose Additional Trial for DCCR

The Foundation for Prader-Willi Research (FPWR) and the Prader-Willi Syndrome Association (PWSA) in the U.S. have asked the U.S. Food and Drug Administration (FDA) to reconsider its request for an additional clinical trial of diazoxide choline controlled release (DCCR) tablets in patients with Prader-Willi syndrome (PWS). Last month, the FDA advised Soleno Therapeutics, the therapy’s developer, that another efficacy trial would be necessary to support any future application seeking DCCR’s approval, despite the significant therapeutic benefits seen in…

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