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FDA Approves Viloxazine Capsules for Adults with ADHD

The approval expands the indication for Qelbree to all patients with ADHD aged 6 years and older, and provides adult patients their first novel non-stimulant option in 20 years.

The US Food and Drug Administration (FDA) has approved viloxazine extended-release capsules (Qlebree) for the treatment of ADHD in adult patients aged ≥18 years old.

The approval, granted to Supernus Pharmaceuticals, expands the indicated ADHD patient age group for viloxazine to children ≥6 years old, adolescents and adults—and makes the extended-release capsule the first novel, nonstimulant option approved for adults with ADHD in 2 decades.

Viloxazine extended-release capsules are indicated as a once-daily flexible-dose nonstimulant drug, available from 200 – 600 mg. In the randomized, double-blind, placebo-controlled phase 3 clinical trial data supporting Supernus’ application to the FDA, patients treated with the drug achieved the primary endpoint in statistically significantly reduced change from baseline in Adult ADHD Investigator Symptom Rating Scale (AISRS) total score versus placebo (P = .004). Investigators also observed a significant improvement in AISRS subscale scores for inattention and hyperactivity/impulsivity symptoms among treated patients.

What’s more, adult patients treated with viloxazine met the key secondary efficacy endpoint of change in Clinical Global Impression – Severity of Illness (CGI-S) scale from baseline to week 6 (P = .0023).

In a podcast interview with HCPLive following the initial FDA approval of viloxazine for children and adolescents last year, Ann C. Childress, MD, of the Center for Psychiatry and Behavioral Medicine, explained the value of the novel, non-controlled therapy in relation to common stimulant therapies.

“By non-controlled, I mean that the drug enforcement administration determined there’s not a risk of abuse with Qelbree after reviewing data from clinical trials—and so of course that makes writing prescriptions easier for clinicians and it makes it easier for patients to fill them,” she said.

Greg Mattingly, MD, founding partner of St. Charles Psychiatric Associates in St. Louis, stressed the importance of the new approval as it relates to the approximate 10 million US adults who have treatable ADHD.

“Until today, nonstimulant ADHD options for adults have been very limited,” Mattingly said in a statement. “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."