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Novel Nonstimulant Approved for ADHD Treatment in Adults
The US Food and Drug Administration has approved an expanded indication for Qelbree (viloxazine extended-release capsules) for the treatment of attention-deficit/hyperactivity disorder (ADHD) in adults, maker Supernus Pharmaceuticals recently announced. The novel nonstimulant was approved for use in pediatric patients ages 6 through 17 with ADHD in April 2021.
“Until today, nonstimulant ADHD options for adults have been very limited,” said Greg Mattingly, MD, founding partner of St. Charles Psychiatric Associates in St. Louis, Missouri, and member of the Psych Congress Steering Committee. “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.”
Quiz: How Many Adults With ADHD Experience Sleep Disturbances?
The approval follows a randomized, double-blind, phase III trial of Qelbree in adults with ADHD. Participants randomized to a daily flexible dose between 200 mg to 600 mg showed a significantly greater decrease in Adult ADHD Investigator Symptom Rating Scale (AISRS) total score between baseline and study end compared with participants who received a placebo. Significant improvement in AISRS subscale scores of inattention and hyperactivity/impulsivity symptoms were also observed with Qelbree, Supernus Pharmaceuticals reported.
Additionally, participants who received Qelbree showed significant improvement on the Clinical Global Impression–Severity of Illness scale at week 6. The medication was well tolerated.
Qelbree is taken once daily for full-day exposure. Its expanded indication marks the first approval of a novel nonstimulant treatment for adults with ADHD in 20 years.
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