New ADHD Therapy Approved!

The U.S. Food and Drug Administration (FDA) recently granted approval to Supernus for an expanded indication for Qelbree® (viloxazine extended-release) for the treatment of ADHD in adults ages ≥18. Last year, Qelbree was approved in children and adolescents aged 6 to 17. Qelbree is a selective norepinephrine reuptake inhibitor, a novel nonstimulant medication that is taken once daily for full-day exposure. Notably, Qelbree is the first nonstimulant treatment for adults with ADHD in 20 years. Nonstimulant options for ADHD have been scarce, limiting viable treatments for patients who prefers nonstimulants.

The FDA approval is based on positive results from a randomized, double blind, placebo-controlled Phase III study of Qelbree in adults with ADHD. In the study of adolescents 12 to 17 years of age, ADHD symptom score reductions were statistically significant for 400 mg, beginning at week 2. In clinical studies, there was no evidence of abuse potential. The most observed adverse reactions, occurring in ≥5% in adult patients, were insomnia, headache, somnolence, fatigue, nausea, decreased appetite, dry mouth, and constipation.

Source: Supernus Announces FDA Approval of Qelbree® for the Treatment of ADHD in Adults