FDA Approves Viloxazine Extended-Release Capsules for ADHD

The FDA has approved viloxazine extended-release capsules (Qelbree; Supernus Pharmaceuticals) for the treatment of attention-deficit hyperactivity disorder (ADHD) in patients 18 years of age and older. Viloxazine extended-release capsules are indicated as a once-daily, flexible-dose nonstimulant drug.

Viloxazine has now been approved for the treatment of ADHD in children 6 years of age and up, adolescents, and adults. Viloxazine extended-release capsules are the first novel, nonstimulant option approved for adults with ADHD in 2 decades, according to Supernus.

“[The] 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 two decades,” said Jack Khattar, president and CEO of Supernus Pharmaceuticals, in a press release.

Approximately 16 million individuals have ADHD in the United States. Although many children outgrow the condition, up to 90% of individuals with ADHD in childhood continue to manage the condition in adulthood, according to Supernus Pharmaceuticals.

A randomized, double-blind, placebo-controlled phase 3 trial showed that patients treated with viloxazineachieved the primary endpoint of a statistically significantly reduced change from baseline in Adult ADHD Investigator Symptom Rating Scale (AISRS) total score compared with placebo (P = .004). The data also showed a significant improvement in AISRS subscale scores for inattention and hyperactivity/impulsivity symptoms among treated patients.

Further, adult patients administered viloxazine achieved the key secondary efficacy endpoint of change in Clinical Global Impression—Severity of Illness (CGI-S) scale from baseline to week 6 (P = .0023).

“Until today, nonstimulant ADHD options for adults have been very limited,” said Greg Mattingly, MD, founding partner of St. Charles Psychiatric Associates in St. Louis, in a press release. “This approval is positive news and offers a new novel option for the millions of American adults who are trying to find the right treatment to manage their ADHD symptoms."

Reference

Supernus Announces FDA Approval of Qelbree® for the Treatment of ADHD in Adults. Supernus Pharmaceuticals. News release. April 29, 2022. https://ir.supernus.com/news-releases/news-release-details/supernus-announces-fda-approval-qelbreer-treatment-adhd-adults