Supernus Marks Five Years of Qelbree FDA Approval with Continued Growth in ADHD Treatment

ROCKVILLE, Md., July 14, 2026

Supernus Pharmaceuticals celebrated the fifth anniversary of the U.S. Food and Drug Administration (FDA) approval of Qelbree® (viloxazine extended-release capsules) for attention-deficit/hyperactivity disorder (ADHD). Since its initial pediatric approval in 2021 and expanded adult indication in 2022, Qelbree has become an established non-stimulant treatment option, with approximately three million prescriptions filled since launch and more than one million prescriptions dispensed during 2025 alone.

Qelbree Continues to Expand Non-Stimulant ADHD Treatment Options

Qelbree remains the first novel non-stimulant ADHD therapy approved in more than a decade and the first non-stimulant treatment approved for adults with ADHD in approximately twenty years. Designed for patients aged six years and older, the once-daily therapy provides 24-hour medication exposure, flexible administration options, including capsule sprinkling, and has demonstrated no evidence of abuse potential. These characteristics have supported its growing adoption among healthcare providers seeking alternatives to stimulant medications.

Differentiated Pharmacology Supported by FDA Label Updates

In January 2025, the FDA approved updated prescribing information highlighting Qelbree’s unique multimodal pharmacodynamic profile. The therapy became the only FDA-approved ADHD treatment with documented serotonin (5-HT2C) receptor activity included in its product labeling, alongside its established effects on norepinephrine. The labeling update also added lactation data, making Qelbree the first ADHD medication to fulfill the FDA’s post-marketing clinical lactation study requirements established under the agency’s 2019 guidance.

Supernus Strengthens Long-Term Commitment to ADHD Care

Beyond commercial growth, Supernus continues to invest in education and patient support through initiatives such as You, Me & Qelbree and Ms. Represented, which focus on increasing awareness of ADHD across different patient populations and encouraging individualized treatment decisions. As the company expands its neuroscience portfolio, Supernus believes Qelbree’s growing body of clinical and real-world evidence reinforces its role as a long-term non-stimulant treatment option for children, adolescents, and adults living with ADHD.

Source: Supernus Pharmaceuticals, press release