Soleno Therapeutics Announces Submission and EMA Validation of Marketing Authorization Application for Diazoxide Choline Prolonged-Release Tablets for the Treatment of Hyperphagia in Patients with Prader-Willi Syndrome

REDWOOD CITY, Calif., May 22, 2025 (GLOBE NEWSWIRE) -- Soleno Therapeutics, Inc. (Soleno) (NASDAQ: SLNO), a biopharmaceutical company developing novel therapeutics for the treatment of rare diseases, today announced that Soleno’s Marketing Authorization Application (MAA) seeking regulatory approval of Diazoxide Choline Prolonged-Release Tablets (previously referred to as DCCR) for the treatment of adults and children four years and older with Prader-Willi syndrome (PWS) who have hyperphagia had been validated by the European Medicines Agency (EMA).

“The validation of our MAA represents the next significant milestone in our mission to deliver this important therapy to the broad PWS community, including those in the EU,” said Anish Bhatnagar, M.D., Chairman and Chief Executive Officer of Soleno Therapeutics. “Based on the data generated, DCCR has the potential to help treat hyperphagia, which is the most life-limiting aspect of PWS. We look forward to working closely with European regulators during the review process and intend to make DCCR available to patients in the EU as expeditiously as possible, if approved.”

Soleno estimates that there are approximately 9,500 patients with PWS in the United Kingdom, France, Germany, Italy and Spain combined¹. The Company has been granted Orphan Drug Designation for diazoxide choline in the EU for the treatment of PWS, which could provide Soleno with up to 10 years of market exclusivity in the EU, if approved, in addition to certain other regulatory and financial incentives.

DCCR was approved by the U.S. Food and Drug Administration (FDA) under the brand name VYKAT XR on March 26, 2025.   

About PWS
Prader-Willi syndrome (PWS) is a rare genetic neurodevelopmental disorder caused by an abnormality in the gene expression on chromosome 15.

The Prader-Willi Syndrome Association USA estimates that PWS occurs in one in every 15,000 live births. The defining symptom of PWS is hyperphagia, a chronic and life-threatening condition characterized by an intense persistent sensation of hunger accompanied by food preoccupations, an extreme drive to consume food, food-related behavior problems, and a lack of normal satiety, which can severely diminish the quality of life for individuals with PWS and their families. Hyperphagia can lead to significant mortality (e.g., stomach rupture, choking, accidental death due to food seeking behavior) and longer term, co-morbidities such as diabetes, obesity, and cardiovascular disease.