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FDA approves that Supernus Pharmaceuticals has received the supplemental new drug application (sNDA) for Qelbree.
FREMONT, CA: The U.S. Food and Drug Administration (FDA) has approved that Supernus Pharmaceuticals has received the supplemental new drug application (sNDA) for Qelbree (viloxazine extended-release capsules) for the treatment of attention-deficit hyperactivity disorder (ADHD) in adult patients. With a user fee goal date (PDUFA date) of April 29, 2022, the sNDA is now officially filed.
Supernus revealed favorable topline results from a Phase III study of Qelbree for the treatment of attention deficit hyperactivity disorder in adults in December 2020. (ADHD). The trial met the primary aim with robust statistical significance compared to placebo in improving ADHD symptoms from baseline to end of the study as judged by the ADHD Investigator Symptom Rating Scale at a daily dose of up to 600mg.
In addition to satisfying the primary efficacy target, the Phase III study fulfilled the critical secondary efficacy endpoint of the Clinical Global Impression, Severity of Illness Scale change from baseline at week 6 with statistical significance. In April 2021, Qelbree got approved in the United States for the treatment of ADHD in children aged 6 to 17.
Jack Khattar, President and CEO of Supernus, said, “We look forward to making Qelbree available to adult patients, if approved by the FDA. Approximately 10 million adults in the U.S. have ADHD, and every adult who has ADHD had it as a child. Adults with ADHD often cope with difficulties at school, at work, and in their personal and family lives.”
Mr. Khattar continued, “We are currently focused on Qelbrees launch in the pediatric market and on providing physicians, parents and patients with a new ADHD treatment that is not a controlled substance with proven efficacy and a tolerable safety profile.”