The U.S. Food and Drug Administration (FDA) continues to call for an additional clinical trial of Soleno Therapeutics’ diazoxide choline controlled release (DCCR) tablets before considering it for approval for Prader-Willi syndrome (PWS). However, the agency agreed that such a trial, if appropriately designed, may involve patients currently receiving the…

One year of treatment with Soleno Therapeutics’ investigational oral therapy diazoxide choline controlled release, known as DCCR, significantly reduced excessive appetite and disease-related behaviors in Prader-Willi syndrome (PWS) patients, according to top-line data from an extension study of the DESTINY PWS Phase 3 trial. These trajectories were significantly…

An additional clinical trial into diazoxide choline controlled release (DCCR) tablets as a potential treatment for the insatiable hunger associated with Prader-Willi syndrome (PWS) continues to be seen as necessary by U.S. Food and Drug Administration (FDA) to support a request for DCCR’s approval. But the agency also encouraged Soleno…

Editor’s Note: This is the second of two articles looking at DCCR, Soleno Therapeutics’ investigational treatment, and the DESTINY-PWS trial. The first can be found here.  Likely next steps for diazoxide choline controlled release (DCCR) tablets, a potential therapy for Prader-Willi syndrome (PWS), remain to be known,…

Diazoxide choline controlled release (DCCR) tablets are an investigational therapy for Prader-Willi syndrome (PWS) that, according to data from a Phase 3 clinical trial and linked extension study, may be the first to control the disorder’s hallmark symptom: hyperphagia, or an insatiable hunger. But the COVID-19 pandemic that…

In interviews, most caregivers of people with Prader-Willi syndrome (PWS) reported an easing in patients’ behavioral symptoms after 13 or more weeks of treatment with diazoxide choline controlled release (DCCR) tablets in a Phase 3 trial or its ongoing extension study. Interviews were given to 48 caregivers of enrolled patients…

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…

The U.S. Food and Drug Administration (FDA) has told Soleno Therapeutics that an additional clinical trial “will be necessary” to support any future application seeking approval of diazoxide choline controlled release (DCCR) tablets for people with Prader-Willi syndrome (PWS), the company said. Soleno had submitted an updated analysis…

The COVID-19 pandemic — which took a heavy toll on people with Prader-Willi syndrome (PWS) and their families, according to a recent webinar — likely influenced the results of the DESTINY PWS Phase 3 trial that was testing the investigational therapy diazoxide choline controlled release (DCCR) at its…

Daily treatment with diazoxide choline controlled release (DCCR) leads to sustained reductions in excessive appetite and other symptoms of Prader-Willi syndrome (PWS), according to updated findings from a Phase 3 trial. “The results from this program continue to demonstrate DCCR’s beneficial impact on hyperphagia [excessive appetite], the…