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Phase 3 Trial Shows Efficacy of Extended-Release Amphetamine Tablets in Adult ADHD
Adults with attention-deficit/hyperactivity disorder (ADHD) who took amphetamine extended-release tablets (Dyanavel XR, Tris Pharma) had statistically significant improvement in symptoms compared with patients who took placebo, according to results from a Phase 3 study published in the Journal of Clinical Psychiatry.
“Amphetamine has a proven track record as an efficacious treatment for improvement in ADHD symptomatology,” researchers wrote. “The efficacy and safety of amphetamine, coupled with the rapid absorption and extended-release profile afforded by the LiquiXR drug delivery system demonstrated in this study, provide a new solid-dose treatment option that can be swallowed whole or chewed for patients with ADHD.”
The double-blind randomized controlled trial included 130 patients, 91 of whom completed the 5-week study. Patients received amphetamine extended-release tablets 5-mg starting dose, or matching placebo, once daily in the morning. At week three, the dose increased to 20 mg.
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At week five, efficacy was assessed using serial Permanent Product Measure of Performance (PERMP) tests. The assessments were administered predose and at 0.5, 1, 2, 4, 8, 10, 12, 13, and 14 hours postdose. The mean PERMP Total score (PERMP-T) across postdose time points was the study’s primary efficacy endpoint.
Across all postdose time points, the mean PERMP-T score was significantly higher with amphetamine extended-release tablets than placebo (302.8 vs 279.6), according to the study. Additionally, significant improvements in PERMP-T scores were observed in the amphetamine extended-release tablet group at 0.5 hours, 1 hour, 2 hours, 4 hours, 8 hours, and 13 hours postdose compared with placebo. While numerical differences at the 10-, 12-, and 14-hour time points also favored the amphetamine extended-release tablet group, the differences were not statistically significant.
The most common adverse events during the study included decreased appetite, insomnia, and dry mouth. Most treatment-emergent adverse events were mild to moderate in severity, and no serious adverse events were reported.
“The results of this study demonstrate the efficacy of the amphetamine extended-release tablet in the treatment of ADHD in adults,” said study principal investigator Andrew J. Cutler, MD, clinical associate professor of psychiatry at SUNY Upstate Medical University. “When you look at the totality of the efficacy results, coupled with what we know about Dyanavel XR pharmacokinetics and pharmacodynamics, you can see that the drug is working shortly after dosing, and is still providing efficacy 13 hours postdose.”
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