Supernus Pharmaceuticals, Inc., a biopharmaceutical company focused on developing and commercializing products for the treatment of central nervous system (CNS) diseases, announced that the U.S. Food and Drug Administration (FDA) approved an expanded indication for Qelbree (viloxazine extended-release capsules) for the treatment of attention deficit hyperactivity disorder (ADHD) in adult patients aged 18 and older. The FDA has now approved Qelbree for the treatment of ADHD in children (starting at age 6), adolescents and adults.
Approximately 16 million children, adolescents, and adults have ADHD in the U.S. While many children with ADHD outgrow it, up to 90% of those diagnosed with ADHD in childhood continue to have ADHD as adults.
Qelbree is a novel nonstimulant taken once-daily for full-day exposure. Efficacy and symptom improvement was observed early in treatment. It has a proven safety and tolerability profile, with no evidence of abuse potential in clinical studies. The approval is based on positive results from a randomized, double blind, placebo-controlled Phase III study of Qelbree in adults with ADHD and represents the first approval of a novel nonstimulant treatment for adults in 20 years.
At a daily flexible-dose between 200mg to 600mg, the Phase III trial met the primary endpoint showing the reduction in the change from baseline of the Adult ADHD Investigator Symptom Rating Scale (AISRS) total score at end of study was statistically significantly greater in adults treated with Qelbree versus placebo (p=0.0040). Significant improvement in AISRS subscale scores of inattention and hyperactivity/impulsivity symptoms were also observed in the study. Moreover, the 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 (CGI-S) Scale at week 6. The active dose was well tolerated.