Qelbree improved symptoms, executive function after 1 year in adults with ADHD
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Key takeaways:
- A total of 159 adults with ADHD were given flexible doses of Qelbree for 12 weeks.
- The drug demonstrated “persistent efficacy” over 1 year, both for ADHD symptoms and executive function.
MIAMI BEACH, Fla. — Administration of Qelbree for up to 1 year showed similar safety, efficacy and tolerability profiles seen in shorter trials with improvement in ADHD symptoms and executive function, according to a study presented here.
“The world needs more nonstimulants for ADHD,” Andrew J. Cutler, MD, associate clinical professor in the department of psychiatry, SUNY Upstate Medical University, told Healio during a poster presentation at the American Society of Clinical Psychopharmacology annual meeting.
“The two most common comorbidities with ADHD are depression and anxiety ... and it’s very important to have different options.”
Approval of Qelbree (viloxazine extended-release capsules, Supernus Pharms) was based on results of a 6-week, double-blind, multicenter, flexible dose phase 3 clinical trial of adults with ADHD. Cutler and colleagues aimed to examine long-term safety and efficacy of viloxizane capsules in that trial’s open-label extension.
A total of 159 individuals received viloxizane extended-release capsules with an initial dose of 200 mg per day for 1 to 2 weeks, then subsequent dose optimization from weeks 2 to 12 based on clinical response and tolerability between 200 mg/day and 600 mg/day. After week 12, supplementation of optimized dose could be accompanied with a stimulant. Safety and efficacy measures were assessed relative to double-blind trial baseline (or open-label extenstion re-entry baseline after the trial’s pause due to COVID-19) at weeks 2, 4 and approximately every 8 weeks thereafter, with the trial planned for 3 years or commercial availability of the drug.
According to results, 81, 50, 30 and nine participants remained in the trial for periods of at least 6, 12, 18 and 24 months, respectively. Nine individuals used adjunctive stimulant medication during the trial.
Researchers found overall ADHD symptoms, as well as executive function rating scale scores, continued improvement over initial study or OLE baseline, with mean±SD Adult ADHD Investigator Symptom Rating Scale total score 37.9±6.34 (n=159) at baseline and 14.5 ±10.18 (n = 51) at week 52.
Most treatment-emergent adverse events were mild or moderate in severity and did not result in study discontinuation. Among primary reasons for early discontinuation were withdrawal of consent (25.6%), loss to follow up (17.7%) or adverse events (17.6%), which were generally similar to those seen in the double-blind phase: insomnia, nausea, headache and fatigue.
“In this study what we demonstrated was persistent efficacy over the course of a year, both for ADHD symptoms and executive function as well as no new safety findings,” Cutler said. “This really helps a clinician understand treating a chronic condition can be done effectively and safely.”