Soleno Therapeutics is seeking approval of diazoxide choline controlled-release (DCCR) tablets in the U.S. for Prader-Willi syndrome (PWS) patients, 4 and older, with excessive hunger. The filing of the new drug application with the U.S. Food and Drug Administration (FDA) follows positive data from an open-label extension…

While food-seeking behaviors normally lessen as people age, they increase over time with Prader-Willi syndrome (PWS), according to a study using the Hyperphagia Questionnaire for Clinical Trials (HQ-CT), a tool commonly used in clinical trials but not in comparing a large PWS patient group to the general population. HQ-CT…

Prader-Willi syndrome (PWS) patients who switched from daily treatment with DCCR (diazoxide choline extended-release tablets) to a placebo experienced worsening excessive hunger, or hyperphagia, and greater body weight gains relative to those who stayed on DCCR. That’s according to top-line data from the new randomized withdrawal period of…

Certain regions of the brain are unusually small in people with Prader-Willi syndrome (PWS), a study reveals. “The present study provides objective evidence of volumetric alterations in the subcortical, limbic, and brainstem structures in individuals with PWS,” its researchers wrote. The study, “Differential volume reductions in…

A year of treatment with DCCR (diazoxide choline controlled release) tablets, Soleno Therapeutics’ investigational therapy for people with Prader-Willi syndrome (PWS), safely led to sustained reductions in excessive hunger and disease-related behaviors, according to two presentations of data from a Phase 3 trial and its open-label extension. Soleno announced positive findings…

Saniona will pause the Phase 2b clinical trials testing Tesomet for people with Prader-Willi syndrome (PWS) and hypothalamic obesity (HO). The decision “is not related to the safety or efficacy of Tesomet and is entirely due to funding limitations,” the company stated in a press release. The…

Soleno Therapeutics has announced that its diazoxide choline controlled release (DCCR) tablets will be evaluated in a clinical trial for people with early-phase Prader-Willi Syndrome (PWS), which will be funded by Running for Research – Prader-Willi Syndrome, an ongoing fundraiser to benefit PWS research operated by the University…

Tonix Pharmaceuticals has entered a research agreement with Inserm Transfert, the private subsidiary of the French National Institute of Health and Medical Research (Inserm), to study the mechanisms behind the reported benefits of the oxytocin hormone in a mouse model of Prader-Willi syndrome (PWS). Inserm Transfert signed the deal…

A Phase 2 study evaluating ARD-101, an investigational, gut-targeting Prader-Willi syndrome (PWS) oral therapy, is now enrolling up to 12 patients, ages 17 to 65. The open-label study, sponsored by Aardvark Therapeutics, the treatment’s developer, will be held at two sites: Children’s Hospital in Colorado, which is…

Levels of several hunger-regulating hormones are dysregulated in people with Prader-Willi syndrome (PWS), which likely contributes to the excessive hunger that characterizes the condition, a study suggests. Clustering patients based on these hormone levels could help to detect PWS and identify targets for therapies, researchers say. The study, “…