Soleno Therapeutics Announces Presentations Featuring VYKAT(TM) XR in Prader-Willi Syndrome at ISPOR 2025
Soleno Therapeutics (NASDAQ: SLNO) announced two upcoming presentations at the ISPOR 2025 conference in Montreal, focusing on their drug VYKAT™ XR (diazoxide choline) for treating hyperphagia in Prader-Willi syndrome (PWS). The first presentation will discuss mortality rates and treatment outcomes from a Phase 3 clinical trial of VYKAT™ XR. The second presentation will examine the healthcare burden of PWS through analysis of emergency department visits and inpatient stays in US claims data. Both presentations will be delivered by Raj Gandhi, PharmD MBA on May 14 and 15, 2025.
Soleno Therapeutics (NASDAQ: SLNO) ha annunciato due presentazioni in programma alla conferenza ISPOR 2025 a Montreal, incentrate sul loro farmaco VYKAT™ XR (diazossido colina) per il trattamento dell'iperefagia nella sindrome di Prader-Willi (PWS). La prima presentazione tratterà i tassi di mortalità e i risultati del trattamento da uno studio clinico di Fase 3 di VYKAT™ XR. La seconda presentazione analizzerà il carico assistenziale della PWS attraverso l'analisi delle visite al pronto soccorso e dei ricoveri ospedalieri basati sui dati delle assicurazioni sanitarie negli Stati Uniti. Entrambe le presentazioni saranno tenute da Raj Gandhi, PharmD MBA il 14 e 15 maggio 2025.
Soleno Therapeutics (NASDAQ: SLNO) anunció dos presentaciones próximas en la conferencia ISPOR 2025 en Montreal, centradas en su medicamento VYKAT™ XR (diazóxido colina) para tratar la hiperfagia en el síndrome de Prader-Willi (PWS). La primera presentación abordará las tasas de mortalidad y los resultados del tratamiento de un ensayo clínico de fase 3 de VYKAT™ XR. La segunda presentación analizará la carga asistencial del PWS mediante el análisis de visitas a urgencias y estancias hospitalarias en datos de reclamaciones de EE. UU. Ambas presentaciones serán impartidas por Raj Gandhi, PharmD MBA los días 14 y 15 de mayo de 2025.
Soleno Therapeutics (NASDAQ: SLNO)는 몬트리올에서 열리는 ISPOR 2025 컨퍼런스에서 프래더-윌리 증후군(PWS)의 과식증 치료를 위한 약물 VYKAT™ XR (디아조사이드 콜린)에 관한 두 가지 발표를 예정하고 있다고 발표했습니다. 첫 번째 발표는 VYKAT™ XR의 3상 임상시험에서의 사망률 및 치료 결과를 다룰 예정입니다. 두 번째 발표는 미국 청구 데이터에서 응급실 방문 및 입원 기록을 분석하여 PWS의 의료 부담을 조사할 것입니다. 두 발표 모두 Raj Gandhi, PharmD MBA가 2025년 5월 14일과 15일에 진행할 예정입니다.
Soleno Therapeutics (NASDAQ : SLNO) a annoncé deux présentations à venir lors de la conférence ISPOR 2025 à Montréal, portant sur leur médicament VYKAT™ XR (diazoxide choline) pour le traitement de l’hyperphagie dans le syndrome de Prader-Willi (PWS). La première présentation abordera les taux de mortalité et les résultats du traitement issus d’un essai clinique de phase 3 de VYKAT™ XR. La seconde présentation analysera le fardeau sanitaire du PWS à travers l’examen des visites aux urgences et des hospitalisations dans les données de réclamations américaines. Les deux présentations seront données par Raj Gandhi, PharmD MBA les 14 et 15 mai 2025.
Soleno Therapeutics (NASDAQ: SLNO) kündigte zwei bevorstehende Präsentationen auf der ISPOR 2025-Konferenz in Montreal an, die sich auf ihr Medikament VYKAT™ XR (Diazoxid-Cholin) zur Behandlung der Hyperphagie beim Prader-Willi-Syndrom (PWS) konzentrieren. Die erste Präsentation wird Sterblichkeitsraten und Behandlungsergebnisse aus einer Phase-3-Studie von VYKAT™ XR vorstellen. Die zweite Präsentation wird die gesundheitliche Belastung durch PWS anhand von Daten zu Notaufnahmebesuchen und stationären Aufenthalten in US-Versicherungsansprüchen analysieren. Beide Präsentationen werden von Raj Gandhi, PharmD MBA am 14. und 15. Mai 2025 gehalten.
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REDWOOD CITY, Calif., May 13, 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 on the burden of Prader-Willi syndrome (PWS) and findings from its clinical development program of VYKAT™ XR (diazoxide choline) extended-release tablets, previously referred to as DCCR, for the treatment of hyperphagia associated PWS at the International Society for Pharmacoeconomics and Outcomes Research (ISPOR) Meeting 2025, which is being held May 13-16, in Montreal, Canada.
Details of the presentations are as follows:
ISPOR 2025
Title: Expected vs. Observed Mortality Rates, Expressed As Number Needed to Treat, From a Phase 3 Clinical Trial Program of Patients With Hyperphagia and Prader-Willi Syndrome Treated With Diazoxide Choline Extended Release (DCCR)
Format: Poster
Session: Poster Session 2
Date/Time: May 14, 6:00 - 7:00 PM ET
Presenter: Raj Gandhi, PharmD MBA
Title: The Burden of Prader-Willi Syndrome on Patients and the Healthcare System: A Cross-Sectional Examination of Emergency Department Visits and Inpatient Stays in US claims
Format: Poster
Session: Poster Session 4
Date/Time: May 15, 6:00 - 7:00 PM ET
Presenter: Raj Gandhi, PharmD MBA
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.
About VYKAT XR
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.
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 ≥
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
Media Contact:
Soleno Therapeutics
media@soleno.life
650-213-8444, #2
FAQ
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