At Soleno Therapeutics, we are fully committed to developing DCCR (diazoxide choline) Extended-Release for the treatment of Prader-Willi syndrome (PWS). At present, this therapy is investigational, which means that it has not been deemed to be safe and effective by regulatory health authorities such as the U.S. Food and Drug Administration (FDA).
We believe it is only through the systematic development process, leading to product approval that we can have the greatest, most positive impact on the patients for whom DCCR is designed to benefit. With these goals in mind, our focus is on directing resources to completing our development program of DCCR to generate the necessary evidence of safety and efficacy required to obtain regulatory approval.
At this time, Soleno is not able to make DCCR available outside of our clinical trials, including under an expanded access program or the “Right to Try” process. We encourage any patients, and their caregivers, interested in gaining access to DCCR or any other investigational therapy to consult their physician regarding the possibility of participating in clinical trials. A listing of our and other clinical trials can be found on publicly accessible databases such as ClinicalTrials.gov.
This is an exciting time for medical and scientific innovation in PWS, and Soleno is proud to be working toward improving the lives of people affected by this disorder.
This policy is issued in compliance with Chapter V, Section 561A of the U.S. Federal Food, Drug, and Cosmetic Act.