Soleno Therapeutics Announces VYKAT(TM) XR Launch

Rhea-AI Summary

Soleno Therapeutics (NASDAQ: SLNO) has officially launched VYKAT™ XR (diazoxide choline) extended-release tablets in the U.S. market, with first prescriptions already delivered to patients. The FDA-approved treatment, specifically designed for hyperphagia in Prader-Willi syndrome (PWS) patients aged four and older, received authorization on March 26, 2025.

VYKAT XR stands as the only FDA-approved treatment for hyperphagia, which is the primary cause of mortality in PWS patients. The company reports strong initial interest in the medication and has implemented Soleno ONE™, a comprehensive support program to facilitate access for patients, caregivers, and healthcare providers.

Healthcare professionals can initiate prescriptions through www.VykatXRHCP.com, while support is available via the dedicated hotline 1-833-SOLENO-1.

Positive

• First-to-market position with only FDA-approved treatment for PWS hyperphagia
• Strong initial market interest reported post-FDA approval
• Comprehensive patient support program already established

Negative

• None.

Insights

Pharmaceutical Market Analyst

Soleno's commercial launch of VYKAT XR represents a significant milestone that transforms the company from development-stage to commercial-stage. As the first and only FDA-approved treatment for hyperphagia in Prader-Willi syndrome (PWS), Soleno has secured an important first-mover advantage in this rare disease market.

The timing is particularly notable - just 19 days from FDA approval to first prescriptions being filled demonstrates impressive launch execution. For rare disease therapies, this rapid time-to-patient access is crucial for establishing market position before potential competitors can enter.

Soleno's implementation of a comprehensive patient support program (Soleno ONE) indicates they've adopted industry best practices for rare disease commercialization. Such programs are essential for navigating the complex reimbursement landscape that typically accompanies orphan drugs.

The market opportunity, while not quantified in the announcement, is meaningful given the unmet need. PWS affects approximately 1 in 15,000 births, and hyperphagia is described as the "leading cause of mortality" in this population, highlighting the clinical importance of this treatment.

Management's statement about "strong interest" and being "fully prepared to meet demand" suggests confidence in their commercial infrastructure and initial prescription trends. For a company of Soleno's size, successfully commercializing their lead asset represents a fundamental business model validation.

Rare Disease Specialist

VYKAT XR's commercial availability represents a watershed moment for the PWS community. Hyperphagia in PWS isn't simply increased appetite - it's an overwhelming, insatiable hunger that leads to life-threatening complications including obesity, metabolic disorders, and in some cases, stomach rupture from extreme food consumption.

The significance of having the first FDA-approved treatment specifically targeting this cardinal symptom cannot be overstated. Until now, management of hyperphagia relied entirely on strict environmental controls, constant supervision, and food security measures that create enormous caregiver burden.

Diazoxide choline's mechanism - modulating ATP-sensitive potassium channels - addresses the hypothalamic dysfunction underlying the hyperphagia, potentially allowing for more normal hunger regulation. The extended-release formulation (XR) suggests improved patient adherence through less frequent dosing.

The availability for patients as young as four years old is particularly valuable, as early intervention may prevent some complications associated with prolonged hyperphagia. The company's development of dedicated patient support systems acknowledges the unique challenges faced by this community.

For a condition where the primary symptom directly threatens survival and significantly impacts quality of life, having a targeted pharmacological intervention represents a paradigm shift in management. The rapid progression from approval to prescription fulfillment indicates the medical community's recognition of this unmet need.

First prescriptions delivered to individuals with PWS

REDWOOD CITY, Calif., April 14, 2025 (GLOBE NEWSWIRE) -- Soleno Therapeutics, Inc. (Soleno) (NASDAQ: SLNO), a biopharmaceutical company developing novel therapeutics for the treatment of rare diseases, today announced the U.S. commercial availability of VYKAT™ XR (diazoxide choline) extended-release tablets, the company’s treatment for hyperphagia in patients four years of age and older with Prader-Willi syndrome (PWS), which was approved by the U.S. Food and Drug Administration (FDA) on March 26, 2025.

Prescriptions of VYKAT XR have now been delivered to the first individuals living with PWS who have been prescribed the medication.

“We are extremely pleased to begin delivering VYKAT XR, the only FDA-approved treatment for hyperphagia, to individuals living with PWS. Hyperphagia, the hallmark condition of PWS, is the leading cause of mortality in the PWS population and creates a significant burden for caregivers,” said Anish Bhatnagar, M.D., Chief Executive Officer of Soleno Therapeutics. “Since FDA approval, we have seen strong interest in VYKAT XR. Our team is fully prepared to meet demand and is well-positioned to execute a successful commercial launch of this first-to-market treatment. These first shipments mark an important step in our efforts to deliver this new treatment to the PWS community and are an exciting milestone reflecting our dedication to ensuring timely access to treatment.”

Soleno has established a comprehensive support program, Soleno ONE™, to assist patients, caregivers and healthcare providers with access to VYKAT XR. For more information, visit www.VykatXR.com or contact Soleno ONE toll-free at 1-833-SOLENO-1 (1-833-765-3661).
Healthcare providers who want to write prescriptions can visit www.VykatXRHCP.com to complete the Start Form and initiate the process for access to treatment.

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.

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, including statements regarding the timing of commercialization of VYKAT XR for the treatment of hyperphagia in individuals with PWS, the potential market opportunity for VYKAT XR and the ability of VYKAT XR to address the unmet needs of the PWS community. 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:
media@soleno.life

FAQ

When did VYKAT XR receive FDA approval for PWS-related hyperphagia treatment?

VYKAT XR received FDA approval on March 26, 2025, for treating hyperphagia in Prader-Willi syndrome patients aged 4 and older.

What is the significance of VYKAT XR's launch for SLNO in the PWS treatment market?

VYKAT XR is the first and only FDA-approved treatment specifically for hyperphagia in PWS patients, positioning SLNO as a pioneer in addressing this critical medical need.

How can patients access SLNO's VYKAT XR treatment for PWS?

Patients can access VYKAT XR through the Soleno ONE support program, available at www.VykatXR.com or by calling 1-833-SOLENO-1.

What age group is eligible for SLNO's VYKAT XR treatment?

VYKAT XR is approved for patients four years of age and older with Prader-Willi syndrome.