Supernus Pharmaceuticals, Inc. 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.
“Until today, nonstimulant ADHD options for adults have been very limited,” said Greg Mattingly, M.D., founding partner of St. Charles Psychiatric Associates in St. Louis, Mo. “This approval is positive news and offers a new novel option for the millions of American adults who are trying to find the right treatment to manage their ADHD symptoms.”
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.
“As a leader in the field of CNS, we are fully committed to better understanding how to treat complex diseases such as ADHD,” said Jack Khattar, President and CEO of Supernus Pharmaceuticals. “Today’s approval marks a major advancement in the treatment of ADHD and is an important milestone just one year after the approval of Qelbree to treat pediatric patients. We are proud to bring a new novel nonstimulant option for adults into the market after two decades.”
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. Please see additional Important Safety Information included below.
1 Qelbree was studied in 4 clinical trials. In one study of children 6 to 11 years of age, ADHD symptom score reductions were statistically significant for 100 mg and 200 mg doses, beginning at week 1. In the study of adolescents 12 to 17 years of age, ADHD symptom score reductions were statistically significant for 400 mg, beginning at week 2. In the flexible-dose study of adults 18 to 65 years of age, ADHD symptom score reductions were statistically significant in the Qelbree patients, beginning at week 2.
IMPORTANT SAFETY INFORMATION
Qelbree may increase suicidal thoughts and actions, in children and adults with ADHD, especially within the first few months of treatment or when the dose is changed. Tell your doctor if you have (or if there is a family history of) suicidal thoughts or actions before starting Qelbree. Monitor your moods, behaviors, thoughts, and feelings during treatment with Qelbree. Report any new or sudden changes in these symptoms right away. Qelbree should not be taken by patients that also take certain anti-depression medicines, especially those called a monoamine oxidase inhibitor or MAOI, or certain asthma medicines.