New call-to-action
New call-to-action
New call-to-action

Encouraging Update from Soleno Therapeutics Regarding DCCR

A study involving participants currently enrolled in the DCCR open-label extension study will be proposed to generate the data needed to support an NDA.

Soleno Therapeutics has provided an update following recent interactions with the U.S. Food and Drug Administration (FDA) regarding the development of once-daily DCCR (diazoxide choline) extended-release tablets for the treatment of Prader-Willi syndrome (PWS).

FPWR Blog Graphics Samples for Susan-1

On January 20, 2022, the Company received official meeting minutes from the December 21, 2021, Type C meeting with the FDA’s Division of Psychiatry. The purpose of the meeting was to discuss the adequacy of the data submitted by Soleno to the FDA in October 2021 to support a potential New Drug Application (NDA) submission for DCCR for the treatment of PWS, as well as possible ways to generate additional controlled clinical data. The FDA indicated they were receptive to a study design involving participants currently enrolled in Study C602, the Company’s ongoing open-label extension study to generate the additional control data necessary to support an NDA. The Company expects to submit a study proposal shortly and, if acceptable, intends to initiate the study thereafter.

“We appreciate the constructive dialogue with the FDA and the potential to obtain additional controlled clinical data from participants already enrolled in C602. This approach would significantly reduce the time and cost to obtain the necessary data,” said Anish Bhatnagar, M.D., Chief Executive Officer of Soleno Therapeutics. “Importantly, we are continuing our preparations for an NDA submission for DCCR while the additional data are being collected.”

Study C602 is an open-label extension study comprised of patients who completed DESTINY PWS, an international, multi-center, randomized, double-blind, placebo-controlled study of DCCR.

DCCR is a novel, proprietary extended-release dosage form containing the crystalline salt of diazoxide and is administered once-daily. The parent molecule, diazoxide, has been used for decades in thousands of patients in a few rare diseases in neonates, infants, children and adults, but has not been approved for use in PWS. Soleno conceived of and established extensive patent protection on the therapeutic use of diazoxide and DCCR in patients with PWS. The DCCR development program is supported by data from five completed Phase 1 clinical studies in healthy volunteers and three completed Phase 2 clinical studies, one of which was in PWS patients. In the PWS Phase 3 study, DCCR showed promise in addressing hyperphagia, the hallmark symptom of PWS, as well as several other symptoms such as aggressive/destructive behaviors, fat mass and other metabolic parameters.

DCCR is one of a number of PWS therapeutics in development.

New call-to-action

Topics: Research

Susan Hedstrom


Susan Hedstrom is the Executive Director for the Foundation for Prader-Willi Research. Passionate about finding treatments for PWS, Susan joined FPWR in 2009 shortly after her son, Jayden, was diagnosed with Prader-Willi Syndrome. Rather than accepting PWS as it has been defined, Susan has chosen to work with a team of pro-active and tireless individuals to accelerate PWS research in order to change the future of PWS. Inspired by her first FPWR conference and the team of researchers that were working to find answers for the syndrome, she joined the FPWR team in 2010 and led the development of the One SMALL Step walk program. Under Susan’s leadership, over $15 million has been raised for PWS related research.