Soleno Therapeutics Announces Oral Presentations Featuring VYKAT(TM) XR in Prader-Willi Syndrome at ESPE and ESE 2025

Rhea-AI Summary

Soleno Therapeutics (NASDAQ: SLNO) announced upcoming presentations of data for VYKAT™ XR (diazoxide choline) at the Joint Congress of ESPE and ESE Meeting 2025 in Copenhagen. VYKAT XR, recently FDA-approved on March 26, 2025, is now available in the US for treating hyperphagia in Prader-Willi syndrome (PWS) patients aged 4 and older. Two presentations are scheduled: a poster on PWS's impact on caregivers and healthcare systems, and an oral presentation on long-term results of the drug's effects on behavior and hyperphagia reduction. PWS affects approximately 1 in 15,000 live births, characterized by hyperphagia - an intense, persistent hunger that can lead to severe health complications. Important safety information includes contraindications for patients with hypersensitivity to diazoxide or thiazides, warnings about hyperglycemia risks, and common side effects including hypertrichosis, edema, hyperglycemia, and rash.

REDWOOD CITY, Calif., May 08, 2025 (GLOBE NEWSWIRE) -- Soleno Therapeutics, Inc. (Soleno) (NASDAQ: SLNO), a biopharmaceutical company developing novel therapeutics for the treatment of rare diseases, today announced that it will present data from its VYKAT^TM XR (diazoxide choline) extended-release tablets, previously referred to as DCCR, clinical development program for the treatment of hyperphagia associated with Prader-Willi syndrome (PWS) at the Joint Congress of European Society for Pediatric Endocrinology (ESPE) and the European Society of Endocrinology (ESE) Meeting 2025, which is being held May 10-13, 2025, in Copenhagen, Denmark.

VYKAT XR was approved by the U.S. Food and Drug Administration (FDA) on March 26, 2025, and is now commercially available to U.S. patients.   

Details of the oral presentations are as follows:

ESPE and ESE 2025

Title:	The Impact of Prader-Willi Syndrome (PWS) on Caregivers and the Healthcare System: A Burden of Illness Study Design
Format:	Poster
Session:	ePosters: Metabolism, Nutrition and Obesity - Part I (available at the start of the meeting)
Date/Time:	Sunday, May 11, 2025, from 16:55 to 17:55 and again on Monday, May 12, 2025, from 17:15 to 17:45
Presenter:	Evelien Gevers, MD, PhD
Title:	Long-Term Results for Diazoxide Choline Extended-Release (DCCR) Tablets in Patients with Prader-Willi Syndrome: Developmental Behaviour Checklist 2 Response and Relationship to Hyperphagia Reductions
Format:	Oral Presentation
Session:	Oral Communications 15: Metabolism, Nutrition and Obesity
Date/Time:	Tuesday, May 13, 2025, from 14:15 – 15:15 (exact time scheduled for 14:25 – 14:35)
Presenter:	Evelien Gevers, MD, PhD

About PWS
The Prader-Willi Syndrome Association USA estimates that PWS occurs in one in every 15,000 live births. The hallmark symptom of this disorder is hyperphagia, a chronic and life-threatening condition characterized by feelings of intense, persistent hunger, food pre-occupation, and an extreme drive to seek and consume food, which can severely diminish the quality of life for individuals with PWS and their families. Additional characteristics of PWS include behavioral problems, cognitive disabilities, low muscle tone, short stature (when not treated with growth hormone), the accumulation of excess body fat, developmental delays, and incomplete sexual development. 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.

INDICATION
VYKAT XR is indicated for the treatment of hyperphagia in adults and pediatric patients 4 years of age and older with Prader-Willi syndrome (PWS).

IMPORTANT SAFETY INFORMATION

Contraindications
Use of VYKAT XR is contraindicated in patients who have a known hypersensitivity to diazoxide, other components of VYKAT XR, or to thiazides.

Warnings and Precautions

Hyperglycemia
Hyperglycemia, including diabetic ketoacidosis, has been reported. Before initiating VYKAT XR, test fasting plasma glucose (FPG) and HbA1c; optimize blood glucose in patients who have hyperglycemia. During treatment, regularly monitor fasting glucose (FPG or fasting blood glucose) and HbA1c. Monitor fasting glucose more frequently during the first few weeks of treatment in patients with risk factors for hyperglycemia.

Risk of Fluid Overload
Edema, including severe reactions associated with fluid overload, has been reported. Monitor for signs or symptoms of edema or fluid overload. VYKAT XR has not been studied in patients with compromised cardiac reserve and should be used with caution in these patients.

Adverse Reactions
The most common adverse reactions (incidence ≥10% and at least 2% greater than placebo) included hypertrichosis, edema, hyperglycemia, and rash.

Please see the full Prescribing Information, including Medication Guide.

About Soleno Therapeutics, Inc.
Soleno is focused on the development and commercialization of novel therapeutics for the treatment of rare diseases. The company’s first commercial product, VYKAT XR (diazoxide choline) extended-release tablets, formerly known as DCCR, is a once-daily oral treatment for hyperphagia in adults and children 4 years of age and older with Prader-Willi syndrome. For more information, please visit www.soleno.life.

Forward-Looking Statements
This press release contains forward-looking statements within the meaning of Section 21E of the Securities Exchange Act of 1934, as amended. All statements other than statements of historical facts contained in this press release are forward-looking statements. In some cases, you can identify forward-looking statements by terms such as "may," "will," "should," "expect," "plan," "anticipate," "could," "intend," "target," "project," "contemplates," "believes," "estimates," "predicts," "potential" or "continue" or the negative of these terms or other similar expressions. These forward-looking statements speak only as of the date of this press release and are subject to a number of risks, uncertainties and assumptions, including those described in the company's prior press releases and in the periodic reports it files with the SEC. The events and circumstances reflected in the company's forward-looking statements may not be achieved or occur and actual results could differ materially from those projected in the forward-looking statements. Except as required by applicable law, the company does not plan to publicly update or revise any forward-looking statements contained herein, whether as a result of any new information, future events, changed circumstances or otherwise.

Corporate Contact:
Brian Ritchie
LifeSci Advisors, LLC
212-915-2578

FAQ

What is VYKAT XR and when was it approved by the FDA for Prader-Willi syndrome?

VYKAT XR (diazoxide choline) is an extended-release tablet approved by the FDA on March 26, 2025, for treating hyperphagia in adults and pediatric patients 4 years and older with Prader-Willi syndrome.

What are the main side effects of SLNO's VYKAT XR treatment?

The most common adverse reactions (occurring in ≥10% of patients and at least 2% more than placebo) include hypertrichosis, edema, hyperglycemia, and rash.

How common is Prader-Willi syndrome according to Soleno Therapeutics?

According to the Prader-Willi Syndrome Association USA, PWS occurs in approximately one in every 15,000 live births.

What presentations will Soleno Therapeutics (SLNO) give at ESPE and ESE 2025?

Soleno will present two studies: a poster on PWS's impact on caregivers and healthcare systems, and an oral presentation on long-term results of VYKAT XR's effects on behavior and hyperphagia reduction.