Supernus Pharmaceuticals, Inc.SUPN
Psychiatry40 cited findings · profile updated 2026-08-26
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About Supernus Pharmaceuticals, Inc.
Supernus Pharmaceuticals, Inc. focuses on psychiatry. Their drug, Qelbree (viloxazine) extended-release capsules, has been approved for the treatment of attention deficit hyperactivity disorder (ADHD) in pediatric patients 6 to 17 years of age. The NDA for viloxazine extended-release capsules was submitted as a 505(b)(1) application under NDA Number 211964.
Clinical trials for Qelbree included four randomized, placebo-controlled, double-blind studies. In Study 812P310, 687 individuals had exposure for at least 6 months in an open-label extension study, and 347 had exposure for at least 1 year. Irritability incidence varied across studies and dosages. For example, in Study 812P202, irritability incidence was 4% for viloxazine and 0% for placebo. In the 12-17 years age group, irritability incidence for Qelbree ranged from 3% (200mg) to 5% (600mg), compared to 1% for placebo. For the 6-11 years age group, irritability incidence for Qelbree ranged from 2% (200mg) to 6% (400mg), compared to 2% for placebo.
Compiled from the cited findings below — figures are as stated in each company's published technical reports and filings.
Key figures — cited
| Approved Indication/Population | Treatment of attention deficit hyperactivity disorder in pediatric patients 6 to 17 years of age | Supernus Pharmaceuticals, Inc. — Qelbree FDA Review (NDA211964, ORIG 1, p.8 |
| Irritability (Study 812P202, Viloxazine) | 4 % | Supernus Pharmaceuticals, Inc. — Qelbree FDA Review (NDA211964, ORIG 1, p.254 |
| Irritability (Study 812P202, Placebo) | 0 % | Supernus Pharmaceuticals, Inc. — Qelbree FDA Review (NDA211964, ORIG 1, p.254 |
| Irritability (12-17 years, Treatment total) | 4 % | Supernus Pharmaceuticals, Inc. — Qelbree FDA Review (NDA211964, ORIG 1, p.249 |
| Irritability (12-17 years, Placebo) | 1 % | Supernus Pharmaceuticals, Inc. — Qelbree FDA Review (NDA211964, ORIG 1, p.249 |
| Number of randomized, placebo-controlled, double-blind studies | 4 | Supernus Pharmaceuticals, Inc. — Qelbree FDA Review (NDA211964, ORIG 1, p.26 |
Key projects
- Qelbree (viloxazine) extended-release capsules (Treatment of attention deficit hyperactivity disorder in pediatric patients 6 to 17 years of age) — US
Approved for the treatment of attention deficit hyperactivity disorder in pediatric patients 6 to 17 years of age.
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