A message from Soleno Therapeutics to our PWS Community:
Changing What it Means to Live with PWS
Soleno Therapeutics is delivering meaningful solutions to individuals living with Prader-Willi syndrome (PWS) through VYKAT™ XR (diazoxide choline) extended-release tablets, the only FDA-approved treatment for patients four years and over to treat the defining feature of PWS: hyperphagia.
In 2018, Soleno began studying the therapy that became VYKAT XR. We understand how difficult living with PWS can be for families, who otherwise have had no therapeutic options for the safe and effective treatment of hyperphagia, the most disruptive aspect of this complex and rare disease.
That is why we focused our efforts on addressing the serious unmet needs of individuals living with PWS and their families. With the safety and efficacy demonstrated, we believe VYKAT XR can become the standard of care therapy for appropriate individuals four years of age and older living with PWS-related hyperphagia.
OUR TRACK RECORD
We are proud of the comprehensive clinical development program we conducted in partnership with our Principal Investigators, their study teams, the advocacy organizations, and the FDA, which led to approval of VYKAT XR.
- We are confident in the integrity and independence of our Principal Investigators and the accuracy of our data.
- The highest enrolling clinical study sites were inspected by the FDA and there were no issues identified that required a response to the FDA.
- We used a validated questionnaire, HQ-CT, to measure the primary endpoint in both double-blind, placebo-controlled clinical trials (Studies C601 and C602 randomized-withdrawal period).
- Multiple peer-reviewed articles have been published and another on the C602 randomized-withdrawal period is expected in the near future.
VYKAT XR has a well-established safety profile with over four years of data across our clinical development program in PWS, which included two double-blind, placebo-controlled studies and two open-label studies.
- Patient experience since commercial launch is consistent with the safety profile in our clinical development program and the FDA-issued prescribing information.
- We are deeply committed to the well-being of individuals living with PWS and the safe, effective use of VYKAT XR in accordance with the FDA-approved labeling.
- We are also committed to partnering with the PWS community, advocates, and healthcare providers to facilitate education and training to the broader prescribing community on the VYKAT XR FDA-approved clinical profile.
- Individuals with PWS often present with multiple co-morbidities that healthcare providers are trained to monitor, consistent with the VYKAT XR prescribing label, and we maintain strict compliance with drug safety reporting.
- Not all people living with PWS-related hyperphagia are appropriate candidates for VYKAT XR. Talk to your healthcare provider to find out more and tell them about all your medical conditions.
Soleno has been fortunate to hear from members of the PWS community who have wanted to share their families’ journeys. We are inspired and heartened by the many positive experiences.
Soleno takes safety seriously. As we see the steady growth in the adoption of VYKAT XR by families and healthcare providers, we are committed to continued education, monitoring, and transparency.
Soleno is grateful for the partnership with the PWS community throughout the clinical development program, the regulatory review process, and the FDA approval of VYKAT XR for individuals living with PWS-related hyperphagia.
Read Soleno's full message here >>
Please see below for Important Safety Information for VYKAT XR (diazoxide choline) extended-release tablets.
