Dear members of the Prader-Willi syndrome community,
One year ago, VYKAT™ XR (diazoxide choline) was approved in the United States as the first FDA-approved treatment for hyperphagia in people ages 4 and older living with Prader-Willi syndrome (PWS). For Soleno, this milestone marks more than an anniversary of our approval. It marks the responsibility of delivering on a commitment we made to this community over a decade ago.
On behalf of the entire Soleno team, thank you for trusting us and for allowing us to walk alongside you during this first year.
From the beginning, we recognized that PWS is a complex, lifelong condition with many interconnected symptoms and comorbidities. Among them, hyperphagia, a chronic and life-threatening feeling of intense, persistent hunger that cannot be satisfied by food, stands apart not as just one feature, but as the most urgent and defining challenge. It often shapes daily life, safety, independence, and long-term outcomes for individuals and families. Where others saw overwhelming complexity, we saw a calling. That conviction continues to guide how we listen, how we act, and how we show up for this community.
What has the first year reinforced for us?
This past year has reinforced a truth, long understood by families and individuals living with hyperphagia associated with PWS: there is no single experience of this condition, and no single measure of progress. Hyperphagia affects individuals and families in deeply personal ways, and meaningful change must be understood in the context of daily life, not just clinical milestones.
We have learned that progress is built through partnership — between individuals, caregivers, healthcare providers, advocates, and the broader rare disease community. Our role is to ensure families have access to a treatment option backed by science and approved for use by the FDA, alongside the education and support needed to make informed decisions.
How is VYKAT XR being used today?
Since approval, VYKAT XR has been prescribed across a broad range of patients 4 years and older experiencing different stages of life, reflecting the diverse hyperphagia with PWS population. Families and clinicians have approached treatment thoughtfully, recognizing that responses vary and that each individual’s journey is unique. We are proud to share that over 850 individuals are on treatment with VYKAT XR.
We remain committed to transparency as we continue to learn from real-world experience and the questions our dedicated Patient and Community Educators (PACE) team is receiving every day. Their role is simple but meaningful: helping people feel informed, supported, and more confident as they navigate their journey. Families and caregivers often share that they are committed and hopeful as they continue to monitor changes over time. Open dialogue with healthcare providers, careful monitoring, and individualized care remain essential components of treatment decision-making.
What are caregivers telling us about VYKAT XR?
Caregivers have shared how managing hyperphagia in PWS often extends far beyond food control. Some have described changes that feel meaningful in daily life; others continue to face challenges that require ongoing support and adjustment.
These perspectives matter. Caregiver insight is not supplemental to science; it strengthens it. Listening to families remains central to how we understand impact and how we continue to evolve our approach.
What remains important to understand about safety and ongoing care for those receiving VYKAT XR under the care of their physician?
Hyperphagia associated with PWS is a complex, multi-system condition, and responses to treatment can differ. Families considering or using VYKAT XR should continue to work closely with their healthcare providers to determine what is appropriate for their individual situation.
Soleno is committed to earning trust through transparency by communicating clearly, sharing safety information responsibly, and holding ourselves to the highest standards of monitoring and accountability.
For individuals that are interested in learning more about VYKAT XR, we encourage you to start with your trusted healthcare provider by sharing how untreated hyperphagia impacts you or your loved one’s daily life.
For more information, including the Full Prescribing Information, Medication Guide, and Important Safety Information, visit www.vykatxr.com and sign up for updates, including opportunities to join educational webinars, at https://www.vykatxr.com/sign-up
How is Soleno supporting the rare disease and Prader-Willi syndrome community beyond treatment?
Our commitment extends beyond a prescription. Over the past year, we have continued to invest in education, community support resources, and partnerships with rare disease advocacy organizations. We aim to ensure families have access to clear information, support navigating coverage, and trusted points of connection throughout their journey.
Just as important, we remain deeply engaged with the community. Your voices guide how we grow, how we prioritize, and how we remain accountable to the people we serve.
One year in, we are focused.
Our journey began with hyperphagia associated with PWS, and our responsibility to this community remains at the center of everything we do. We will continue to advance care, support education and awareness, and work toward a future where individuals living with PWS have more options, greater understanding, and sustained support across their lifetimes.
Thank you for allowing us to be part of this journey and for holding us to the standard this community deserves.
With gratitude,
The Soleno Therapeutics Team
*/
