The US Food and Drug Administration has approved Supernus Pharmaceuticals’ Qelbree for the treatment of attention-deficit hyperactivity disorder (ADHD) in patients aged 6 to 17 years, making it the first novel nonstimulant approved for ADHD in a decade, Supernus announced.
Qelbree (viloxazine extended-release capsules) is expected to be available within the next 3 months.
“Based on the efficacy demonstrated in the clinical program, we believe Qelbree offers a unique new alternative for the treatment of ADHD,” Supernus president and chief executive officer Jack A. Khattar said. “Qelbree provides prescribing physicians and patients living with ADHD a therapy that is not a controlled substance with proven efficacy and a tolerable safety profile.”
The development of Qelbree, a selective norepinephrine reuptake inhibitor, included 4 phase 3 clinical trials encompassing more than 1000 pediatric patients. Capsules can be swallowed whole or their contents can be sprinkled onto food.
Qelbree, formerly known as SPN-812, will carry a black box warning about higher rates of suicidal thoughts and behavior that were reported in pediatric patients treated with Qelbree during clinical trials, compared with patients treated with placebo. The most commonly observed adverse reactions in patients taking Qelbree were somnolence, decreased appetite, fatigue, nausea, vomiting, insomnia, and irritability, according to the drug’s Prescribing Information.
In a statement, the company said it plans to submit a supplemental New Drug Application for Qelbree to the FDA in the second half of 2021 for the treatment of ADHD in adults. Positive results from a phase 3 trial with adult patients were announced in December.