The Food and Drug Administration has accepted for review the supplemental New Drug Application for viloxazine extended-release for the treatment of attention-deficit hyperactivity disorder in adults.
The application is supported by data from a multicenter, randomized, double-blind, placebo-controlled phase 3 trial (ClinicalTrials.gov Identifier: NCT04016779), which assessed the efficacy and safety of viloxazine in 374 adults with ADHD. The trial included a 2-arm flexible dose design, in which patients were randomly assigned to receive a daily dose of viloxazine starting with 200mg up to 600mg or placebo.
Results showed that treatment with viloxazine met the primary endpoint demonstrating statistically significant improvements in ADHD symptoms compared with placebo at week 6 as assessed by the adult ADHD Investigator Symptom Rating Scale (-15.5 point change vs -11.7 point change, respectively; P =.004). Treatment with viloxazine was also associated with statistically significant improvement vs placebo on the Clinical Global Impression – Severity of Illness Scale at week 6 (P =.0023).
A Prescription Drug User Fee Act (PDUFA) target date of April 29, 2022 has been set for the application.
Viloxazine is currently marketed under the trade name Qelbree and is indicated for the treatment of ADHD in patients 6 to 17 years of age. Qelbree is supplied as extended-release capsules containing 100mg, 150mg, or 200mg of viloxazine.
- Supernus announces Qelbree™ sNDA for adult indication accepted for review by FDA. News release. Supernus Pharmaceuticals, Inc. September 2, 2021. Accessed September 7, 2021. https://www.globenewswire.com/news-release/2021/09/02/2291229/19871/en/Supernus-Announces-Qelbree-sNDA-for-Adult-Indication-Accepted-for-Review-by-FDA.html.
- Supernus announces positive results from phase III study for SPN-812 in adults with ADHD. News release. Supernus Pharmaceuticals, Inc. December 22, 2020. Accessed September 7, 2021. https://ir.supernus.com/news-releases/news-release-details/supernus-announces-positive-results-phase-iii-study-spn-812-0.