The Food and Drug Administration (FDA) has approved Qelbree™ (viloxazine extended-release capsules; Supernus Pharmaceuticals), a serotonin norepinephrine reuptake inhibitor, for the treatment of attention-deficit hyperactivity disorder (ADHD) in patients 6 to 17 years of age.
The approval was based on data from an extensive development program that included four phase 3 studies involving more than 1000 patients 6 to 17 years of age with ADHD. The efficacy of Qelbree was evaluated in 3 randomized, double-blind, placebo-controlled, monotherapy phase 3 studies (ClinicalTrials.gov: NCT03247530, NCT03247543 and NCT03247517). The primary endpoint for all studies was the change from baseline in ADHD Rating Scale (ADHD-RS-5), an 18-question scale that assesses hyperactivity, impulsivity, and inattentive symptoms. The key secondary endpoint was the Clinical Global Impression-Improvement (CGI-I) score.
Findings showed that treatment with Qelbree resulted in statistically significantly greater reductions in ADHD-RS-5 total score compared with placebo. Moreover, a statistically significantly greater reduction in CGI-I score was observed with Qelbree.
As for safety, Qelbree demonstrated a favorable profile that was consistent across all phase 3 studies with a low occurrence of adverse events. The most common treatment-emergent adverse events reported were somnolence, decreased appetite, fatigue, nausea, vomiting, insomnia, and irritability.
Qelbree is contraindicated for use in patients receiving concomitant treatment with monoamine oxidase inhibitors (MAOI), or within 14 days after discontinuing an MAOI, and in patients receiving concomitant administration of sensitive CYP1A2 substrates or CYP1A2 substrates with a narrow therapeutic range. Qelbree also carries a Boxed Warning as higher rates of suicidal thoughts and behavior were reported in pediatric patients with ADHD treated with Qelbree than in patients treated with placebo.
“Based on the efficacy demonstrated in the clinical program, we believe Qelbree offers a unique new alternative for the treatment of ADHD,” said Jack A. Khattar, President and Chief Executive Officer of Supernus Pharmaceuticals. “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.”
Qelbree is supplied as extended-release capsules containing 100mg, 150mg, or 200mg of viloxazine and is expected to be available in the second quarter of 2021. The Company also plans to submit a supplemental New Drug Application for Qelbree for adult ADHD in the second half of 2021.
1. Supernus announces FDA approval of Qelbree™ (SPN-812) for the treatment of ADHD. [press release]. Rockville, MD: Supernus Pharmaceuticals, Inc.; April 2, 2021.
2. Qelbree [package insert]. Rockville, MD: Supernus Pharmaceuticals, Inc.; 2021.