Soleno Therapeutics has announced that the FDA will accept additional data from their DESTINY PWS and C602 extension study to determine if the data generated are sufficient to support a potential New Drug Application (NDA) for diazoxide choline contr...
Levo Therapeutics has announced the FDA has granted Priority Review for its New Drug Application (NDA) for LV-101 (intranasal carbetocin) as a treatment for hyperphagia and behavioral distress associated with PWS. A 6-month Priority Review will accel...
A new long-term study on scoliosis and growth hormone has been published. The publication, Effects of 8 Years of Growth Hormone Treatment On Scoliosis In Children With Prader-Willi Syndrome shows that 8 years of growth hormone treatment has no advers...
Topics: Research
In support of our mission to advance the development of new treatments for Prader-Willi syndrome (PWS), FPWR announces our newest venture philanthropy investment in Aardvark Therapeutics.
Topics: News
Individuals with PWS suffer from a variety of digestive and gastrointestinal issues (GI), some of which can lead to surgery. Here, we focus on data from the Global PWS Registry to provide information on the prevalence of gastroparesis (delayed stomac...
Topics: Research
In this 30‑minute video, Albena Patroneva from Harmony Biosciences explains what pitolisant is and how it works, and describes Harmony's Phase 2 clinical trial of pitolisant in patients with PWS. The session includes Q&A from participants in the ...
Topics: Research
For more than a decade, FPWR has partnered with families and other PWS groups (PWSA|USA, IPWSO) to advocate for PWS treatments. We've worked diligently to build resources that address the FDA’s call for patient experience data, demonstrating high dis...
Topics: Research
In a continuation of our joint advocacy efforts supporting the full review of potential drugs for PWS, FPWR and PWSA | USA have submitted a petition letter to the FDA requesting that they apply regulatory flexibility and to review a New Drug Applicat...
Topics: News
The Foundation for Prader-Willi Research announces our first round of Research Awards in 2021 totaling $359,100. FPWR is dedicated to supporting research that advances the understanding and treatment of Prader-Willi syndrome (PWS) and to that end, ha...
Topics: Research