Supernus Pharmaceuticals, Inc. — Qelbree FDA Review (NDA211964, ORIG 1, 2021)
Supernus Pharmaceuticals, Inc. · 2021 · FDA Review (openFDA) · company profile →
Report summary
Supernus Pharmaceuticals received FDA approval for Qelbree (viloxazine extended-release capsules) for pediatric ADHD (6-17 years) after addressing manufacturing and labeling issues, including a boxed warning for suicidal ideation. Clinical trials demonstrated significant efficacy in reducing ADHD symptoms (ADHD-RS-5 scores). While generally well-tolerated, safety concerns include dose-dependent increases in heart rate and blood pressure, decreased appetite, weight changes, and a potential for suicidal ideation. Animal studies also noted CNS toxicity and liver findings. Viloxazine is metabolized by CYP2D6, and its exposure is affected by renal impairment. The drug has no abuse potential. Post-marketing studies for younger age groups are planned.
Key findings — cited to the page
| Irritability incidence | 3.3 % | · p.30 |
| Irritability (12-17 years, Placebo) | 1 % | · p.249 |
| Irritability (6-11 years, 200mg) | 2 % | · p.249 |
| Irritability (6-11 years, Placebo) | 2 % | · p.249 |
| Irritability (12-17 years, 600mg) | 5 % | · p.249 |
| Irritability (12-17 years, Treatment total) | 4 % | · p.249 |
| Irritability (12-17 years, 200mg) | 3 % | · p.249 |
| Irritability (6-11 years, 100mg) | 3 % | · p.249 |
| Irritability (6-11 years, 400mg) | 6 % | · p.249 |
| Irritability (6-11 years, Treatment total) | 3 % | · p.249 |
| Irritability (12-17 years, 400mg) | 4 % | · p.249 |
| Irritability (Total Treatment) | 4 % | · p.249 |
Source: Supernus Pharmaceuticals, Inc. ↗ · License: US Government public domain. Summary and findings are extracted from the published document; every figure cites its page. Informational only — not investment advice. Explore the Psychiatry library →