FDA Approves Expanded Indication for Viloxazine Extended-Release Capsules for Adults With ADHD

The approval makes the drug the first novel nonstimulant ADHD therapy approved in the last 20 years.

The FDA has approved an expanded indication for viloxazine extended-release capsules (Qelbree) for the treatment of ADHD in adults, following an initial approval for treatment in children and adolescents age 6 and older.1

Viloxazine extended-release capsules are a novel nonstimulant medication administered once daily. Both efficacy and symptom improvement were noticed “early in treatment,” according to a Supernus Pharmaceuticals press release. The expanded approval was based on the positive results of a randomized, double-blind, placebo-controlled phase 3 study of viloxazine extended-release in adults with ADHD, representing the first approval of a novel nonstimulant ADHD therapy for adults in the last 20 yeas.

Viloxazine extended-release capsules are available in flexible doses between 200 mg and 600 mg. In the phase 3 trial, the drug met the primary endpoint, with a statistically significant reduction in change from baseline of the Adult ADHD Investigator Symptom Rating Scale (AISRS) total score by the end of the study in adults treated with viloxazine extended-release capsules vs placebo. The drug also met the key secondary efficacy endpoint—change from baseline in the Clinical Global Impression—Severity of Illness scale at week 6—with statistical significance.

“As a leader in the field of CNS, we are fully committed to better understanding how to treat complex diseases such as ADHD,” said Jack Khattar, Supernus Pharmaceuticals president and CEO. “Today’s approval marks a major advancement in the treatment of ADHD and is an important milestone just 1 year after the approval of Qelbree to treat pediatric patients. We are proud to bring a new novel nonstimulant option for adults into the market after 2 decades.”

Reference

  1. Supernus announces FDA approval of Qelbree® for the treatment of ADHD in adults. News release. Supernus Pharmaceuticals. Published May 2, 2022. Accessed May 13, 2022. https://www.prnewswire.com/news-releases/supernus-announces-fda-approval-of-qelbree-for-the-treatment-of-adhd-in-adults-301537152.html