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Foundation for Prader-Willi Blog | News (9)

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FPWR and PWSA | USA Announce Upcoming Meeting with FDA

With your support, FPWR and PWSA | USA have been granted a meeting with the FDA, which will take place via teleconference later this month. This small, non-public meeting will allow FPWR and PWSA | USA to connect first-hand with the FDA staff and sha...
June 8, 2021 Read More

Topics: News

An Update Letter From Soleno Therapeutics

Dear members of the PWS community, We at Soleno Therapeutics would like to provide an update on the status of DCCR. As we have worked with the PWS community over the last several years, whether it is with advocacy leaders from PWSA USA and FPWR, or w...
April 14, 2021 Read More

Topics: News

Drug Development, the FDA and the Role of the PWS Community [WEBINAR]

Where are we with respect to new treatments for PWS? What are our next steps and how can the patient community help ensure that treatments for PWS are made available as soon as possible? In this webinar, our panelists discuss:
April 12, 2021 Read More

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FPWR and PWSA|USA Request FDA Apply Regulatory Flexibility

FPWR and PWSA|USA have submitted a petition letter to the FDA requesting them to apply regulatory flexibility and to review a New Drug Application for DCCR (diazoxide choline extended-release).
April 8, 2021 Read More

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FDA requires additional trial to support NDA submission for DCCR in PWS

Soleno Therapeutics announced today that the FDA will require an additional controlled clinical trial to support an NDA submission for DCCR in PWS. This is despite pre-Covid data that showed statistically significant changes for DCCR compared to plac...
March 8, 2021 Read More

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Saniona Receives U.S. FDA Orphan Drug Designation for Tesomet in Prader-Willi Syndrome

Saniona has received an orphan drug designation for their drug, Tesomet, for the treatment of PWS. Orphan drug designation is a special status granted by the FDA for drugs intended to treat rare diseases that affect fewer than 200,000 people in the U...
March 3, 2021 Read More

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Tonix Pharmaceuticals Licenses Technology for Treating Prader-Willi Syndrome

Tonix Pharmaceuticals has licensed technology using oxytocin-based therapeutics from the French National Institute of Health and Medical Research (INSERM) to treat Prader-Willi Syndrome. The co-exclusive license allows Tonix to expand its development...
February 26, 2021 Read More

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Soleno Therapeutics and Vanderbilt University Announce Collaboration to Develop New K(ATP) Channel Activators

Soleno Therapeutics and Vanderbilt University announce a new collaboration which aims to discover and develop novel KATP channel activators with the potential to treat rare diseases. Soleno’s lead product candidate, DCCR, is a potent activator of KAT...
February 24, 2021 Read More

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Radius Health Announces Plans for Pivotal Trial of Synthetic CBD

Radius Health has announced its acquisition of RAD011, a synthetic cannabidiol oral solution, which may be a potential treatment for hyperphagia in people with Prader-Willi Syndrome. The Company plans to initiate a pivotal Phase 2/3 study for patient...
January 6, 2021 Read More

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About FPWR

The Foundation for Prader-Willi Research (federal tax id 31-1763110) is a nonprofit corporation with federal tax exempt status as a public charity under section 501(c)(3).

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The mission of FPWR is to eliminate the challenges of Prader-Willi syndrome through the advancement of research and therapeutic development.

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