Supernus Pharmaceuticals, Inc. (Nasdaq: SUPN), a biopharmaceutical company focused on developing and commercializing products for the treatment of central nervous system (CNS) diseases, today announced that the U.S. Food and Drug Administration (FDA) has acknowledged it 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. The sNDA is now considered filed, with a user fee goal date (PDUFA date) of April 29, 2022.
In December 2020, Supernus announced positive topline results from a Phase III study of Qelbree in adults for the treatment of attention deficit hyperactivity disorder (ADHD). The results showed that at a daily dose of up to 600mg, the trial met the primary endpoint with robust statistical significance (p=0.0040) compared to placebo in improving the symptoms of ADHD from baseline to end of study as measured by ADHD Investigator Symptom Rating Scale. In addition to meeting the primary efficacy endpoint, the Phase III study met the key secondary efficacy endpoint with statistical significance (p=0.0023) in the change from baseline of the Clinical Global Impression – Severity of Illness Scale at week 6. The active dose was well tolerated.
Qelbree was approved in the U.S. in April 2021 for the treatment of ADHD in pediatric patients 6 to 17 years of age.
https://finance.yahoo.com/news/supernus-announces-qelbree-snda-adult-224500388.html
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