Supernus Marks Five Years of Qelbree: The First Novel Non-Stimulant ADHD Treatment in Over a Decade
核心洞察
Qelbree (viloxazine extended-release capsules) celebrates its fifth anniversary since FDA approval, with approximately 3 million prescriptions filled since launch and over 1 million in 2025 alone.
It remains the first novel non-stimulant ADHD (搜索) medication approved in over a decade and the only ADHD treatment with serotonin (5-HT2C) (搜索) pharmacodynamics in its FDA labeling.
Originally approved for pediatric patients in April 2021, Qelbree gained an expanded indication for adults in April 2022, marking the first non-stimulant adult ADHD (搜索) option in two decades.
ROCKVILLE, Md., July 14, 2026 — Supernus Pharmaceuticals, Inc. (Nasdaq: SUPN) today celebrates the five-year anniversary of the U.S. Food and Drug Administration approval of Qelbree (viloxazine extended-release capsules) for attention-deficit/hyperactivity disorder (ADHD (搜索)). Since its initial approval for pediatric patients aged 6 to 17 years in April 2021, and subsequent approval for adults in April 2022, Qelbree has established itself as a differentiated non-stimulant option in a therapeutic area affecting nearly 16 million adults and 7 million children and teens in the United States.
Qelbree was the first novel, non-stimulant approach to ADHD (搜索) in over a decade. It remains the only ADHD treatment with serotonin (5-HT2C) (搜索) pharmacodynamics approved in its FDA product labeling, offering a multimodal pharmacodynamic profile that increases norepinephrine while also acting as a partial agonist at the serotonin (5-HT2C) receptor.
Real-World Adoption and Clinical Utility
Five years after market introduction, Qelbree has seen substantial uptake, with approximately 3 million total prescriptions filled since launch and over 1 million prescriptions filled in 2025 alone. As a non-controlled treatment option with no evidence of abuse potential, Qelbree provides 24-hour medication exposure and versatile administration — including the ability to be sprinkled and taken at any time of day — offering added flexibility for patients and healthcare providers.
“ADHD (搜索) care is ever-changing, but one thing remains constant: the need for flexible treatment options that enable healthcare providers and patients to make truly tailored decisions. For the past five years, Qelbree has delivered on this need, standing as a trusted choice for many,” said Jack A. Khattar, President and Chief Executive Officer of Supernus Pharmaceuticals. “ADHD can present differently throughout a person’s life – from childhood through adulthood. Our focus has been on delivering a versatile treatment option with demonstrated safety and efficacy that can be used in real-world clinical practice.”
Expanded Indication and Evolving Understanding of ADHD (搜索)
Recognizing that approximately 90% of children with ADHD (搜索) continue to have symptoms into adulthood, Supernus secured an expanded indication from the FDA in April 2022 for the treatment of ADHD in adults aged 18 years and older. This marked the first non-stimulant treatment option for adults in two decades, addressing a significant gap in the therapeutic landscape.
January 2025 Labeling Update
In January 2025, the FDA approved labeling updates for Qelbree to include additional pharmacodynamic data, reinforcing its differentiated mechanism of action. The update also included lactation data for breastfeeding women, making Qelbree the first ADHD (搜索) treatment to meet this post-marketing requirement and receive labeling approval following the 2019 FDA guidance on Clinical Lactation Studies.
Safety Profile and Administration
Qelbree carries a Boxed Warning regarding increased risk of suicidal thoughts and actions in children and adults with ADHD (搜索), particularly within the first few months of treatment or when the dose is changed. The most common side effects in patients aged 6 to 17 years include sleepiness, decreased appetite, fatigue, nausea, vomiting, insomnia, and irritability. In adults, the most common side effects are insomnia, headache, sleepiness, tiredness, nausea, decreased appetite, dry mouth, and constipation. Qelbree is available in 100 mg, 150 mg, and 200 mg capsules.
Ongoing Commitment to the ADHD (搜索) Community
Supernus continues to expand its support for the ADHD (搜索) community through initiatives such as the “You, Me & Qelbree” and “Ms. Represented” campaigns, which aim to share real-life patient experiences, educate on the different ways symptoms can present — particularly between men and women — and highlight the role of support systems in disease management.
“This five-year milestone is a testament to the data, but also to the dedication of the whole Supernus team, whose continued hard work has helped make it possible,” Khattar concluded.