Margarida Maia, PhD,  science writer—

Aardvark Therapeutics plans to expand its ongoing Phase 3 clinical trial of ARD-101, an oral therapy for easing excessive hunger in Prader-Willi syndrome (PWS), to include patients younger than 13. The decision, supported by the PWS community, is based on historical data indicating that younger PWS patients are…

A year of treatment with somatropin safely maintains or improves body composition in Japanese children and adults with Prader-Willi syndrome (PWS). The findings come from a Pfizer-funded Phase 3 clinical trial (NCT04697381) that evaluated somatropin’s one-year safety and efficacy in 33 PWS patients on stable growth hormone treatment…

Most children and adolescents with Prader-Willi syndrome (PWS) experience frequent anxiety and engage in distress-related behaviors that become a regular part of daily life for their families. That’s according to results from a survey completed by caregivers at the start of the Phase 3 CARE-PWS clinical trial (NCT03649477),…

Vykat XR (diazoxide choline) can safely reduce hyperphagia — a feeling of insatiable hunger that is a hallmark of Prader-Willi syndrome (PWS) — in patients whose access to food has been restricted and in those with pre-diabetes or diabetes. These data were presented in two poster presentations at…

After discontinuing Vykat XR (diazoxide choline) for a few months as part of a clinical trial, Prader-Willi syndrome (PWS) patients who restarted the treatment showed sustained reductions in insatiable hunger, or hyperphagia, and behavioral problems. The results were presented in a poster, titled “Resuming diazoxide choline extended-release (DCCR)…

Thanks to strong enrollment in a Phase 3 clinical trial of Acadia Pharmaceuticals’ ACP-101 — an experimental nasal spray of carbetocin for treating hyperphagia in Prader-Willi syndrome (PWS) — the company announced that it now expects to have top-line data later this year. That trial, COMPASS PWS…

The first eligible Prader-Willi syndrome (PWS) patients in the U.S. have received their prescriptions for Vykat XR (diazoxide choline) — the once-daily, extended-release tablets now approved as a treatment for hyperphagia, or insatiable hunger, in people with PWS, ages 4 and older. Soleno Therapeutics’ Vykat XR became…

The U.S. Food and Drug Administration (FDA) has approved Soleno Therapeutics’ extended-release formulation of diazoxide choline (DCCR) for easing hyperphagia — marked by insatiable hunger — in Prader-Willi syndrome (PWS) patients ages 4 and older. The newly authorized oral therapy will be marketed under the brand name…

Rhythm Pharmaceuticals plans to start a new Phase 2 clinical study in the first quarter of 2025 to test setmelanotide in adults and children with Prader-Willi syndrome (PWS). An investigational therapy for PWS, setmelanotide is approved in the U.S. to treat certain types of genetic obesity under the…

The U.S. Food and Drug Administration (FDA) will review Soleno Therapeutics’ application seeking approval of its extended-release formulation of diazoxide choline (DCCR) for Prader-Willi syndrome (PWS) in patients, 4 and older, with excessive hunger. The new drug application (NDA), filed in July, was granted priority review, shortening…