Qelbree / viloxazine ER
Psychiatry· 1562 cited findings· 1 source document
Company: Supernus Pharmaceuticals, Inc. →
What the regulatory reviews say
Qelbree (viloxazine ER) is approved for the treatment of attention deficit hyperactivity disorder (ADHD) in pediatric patients 6 to 17 years of age. The New Drug Application (NDA 211964) received approval following a Complete Response Letter issuance on November 6, 2020, with a PDUFA Goal Date of April 3, 2021. The NDA was submitted as a 505(b)(1) application.
Efficacy was evaluated in four randomized, placebo-controlled, double-blind studies. Key findings include a -7.2 change in ADHD-RS-5 Total Score LS Mean Difference from Placebo for SPN-812 ER 100 mg/day, and a -7.8 change for SPN-812 ER 200 mg/day. Other efficacy measures showed ADHD-RS-5 total score changes from baseline (LS mean difference vs placebo) ranging from -4.5 to -6.9. A CGI-I scale improvement of -0.5 was also observed.
Safety data included a Boxed Warning for suicidal ideation and behavior. Discontinuation due to adverse events was 3.5%. Common adverse events included somnolence/sedation (16.1%), headache (6.9%), decreased appetite (7.4%), fatigue (6.4%), abdominal pain (5.4%), and nausea (4.6%). Exposure in open-label extension studies included 687 subjects for at least 6 months and 347 for at least 1 year.
Key figures — cited to the source page
| ADHD-RS-5 Total Score LS Mean Difference from Placebo (SPN-812 ER 100 mg/day) | -7.2 | Supernus Pharmaceuticals, Inc. — Qelbree FDA Review (NDA2119, p.239 |
| ADHD-RS-5 Total Score LS Mean Difference from Placebo (SPN-812 ER 200 mg/day) | -7.8 | Supernus Pharmaceuticals, Inc. — Qelbree FDA Review (NDA2119, p.239 |
| CGI-I scale improvement | -0.5 | Supernus Pharmaceuticals, Inc. — Qelbree FDA Review (NDA2119, p.59 |
| Boxed Warning | suicidal ideation and behavior | Supernus Pharmaceuticals, Inc. — Qelbree FDA Review (NDA2119, p.3 |
| Discontinuation due to adverse events | 3.5 | Supernus Pharmaceuticals, Inc. — Qelbree FDA Review (NDA2119, p.30 |
| Somnolence/sedation incidence | 16.1 | Supernus Pharmaceuticals, Inc. — Qelbree FDA Review (NDA2119, p.30 |
| NDA approval | Approval | Supernus Pharmaceuticals, Inc. — Qelbree FDA Review (NDA2119, p.2 |
| Approved Indication/Population | Treatment of attention deficit hyperactivity disorder in pediatric patients 6 to 17 years of age | Supernus Pharmaceuticals, Inc. — Qelbree FDA Review (NDA2119, p.8 |
Source documents
Explore the full evidence
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Figures are as stated in the cited regulatory review documents (different drugs are studied in different trials — values are not head-to-head comparisons). Educational reference only — not medical or investment advice.