January 24 ,2022 -- PWSA| USA is sharing the most recent news released on the status of Soleno Therapeutics' drug DCCR (diazoxide choline) for the treatment of Prader-Willi syndrome. Soleno announced today that it has received the official minutes from a December 2021 meeting with the FDA's Division of Psychiatry. This meeting was a follow up to an October 2021 meeting where Soleno sought out the FDA's support of a New Drug Application (NDA) for DCCR. In this October meeting with the FDA, Soleno shared data from their Study C602.
Based on the FDA's official meeting minutes, which was sent to Soleno on January 20, 2022, they have asked the drug company to continue with their testing and provide further data from those currently enrolled in Study C602.
"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."
To read the full news release, please click here.
PWSA | USA will continue to provide updates on the progress of DCCR and the information shared by Soleno and the FDA.
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Jennifer Bolander has been serving as a Special Education Specialist for PWSA (USA) since October of 2015. She is a graduate of John Carroll University and lives in Ohio with her husband Brad and daughters Kate (17), and Sophia (13) who was born with PWS.
Perry A. Zirkel has written more than 1,500 publications on various aspects of school law, with an emphasis on legal issues in special education. He writes a regular column for NAESP’s Principal magazine and NASP’s Communiqué newsletter, and he did so previously for Phi Delta Kappan and Teaching Exceptional Children.
Evan has worked with the Prader-Willi Syndrome Association (USA) since 2007 primarily as a Crisis Intervention and Family Support Counselor. Evans works with parents and schools to foster strong collaborative relationships and appropriate educational environments for students with PWS.
Dr. Amy McTighe is the PWS Program Manager and Inpatient Teacher at the Center for Prader-Willi Syndrome at the Children’s Institute of Pittsburgh. She graduated from Duquesne University receiving her Bachelor’s and Master’s degree in Education with a focus on elementary education, special education, and language arts.
Staci Zimmerman works for Prader-Willi Syndrome Association of Colorado as an Individualized Education Program (IEP) consultant. Staci collaborates with the PWS multi-disciplinary clinic at the Children’s Hospital in Denver supporting families and school districts around the United States with their child’s Individual Educational Plan.
Founded in 2001, SDLC is a non-profit legal services organization dedicated to protecting and advancing the legal rights of people with disabilities throughout the South. It partners with the Southern Poverty Law Center, Protection and Advocacy (P&A) programs, Legal Services Corporations (LSC) and disability organizations on major, systemic disability rights issues involving the Individuals with Disabilities Education Act (IDEA), Americans with Disabilities Act (ADA), and the federal Medicaid Act. Recently in November 2014, Jim retired.