FDA approval of Qelbree for the treatment of ADHD in adults
Supernus Pharmaceuticals, Inc. announced that the 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.
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