Investigational ADHD Treatment Meets Primary Endpoint in Phase 3 Trial

An investigational extended-release amphetamine tablet met its primary efficacy endpoint—sustained attention in adults with attention-deficit/hyperactivity disorder (ADHD)—in a phase 3 trial, Tris Pharma Inc. recently announced.

Researchers shared findings from the randomized, double-blind, placebo-controlled trial in a poster presentation at the virtual 2021 meeting of the American Professional Society of ADHD and Related Disorders (APSARD).

According to the reported study results, the average Permanent Product Measure of Performance total (PERMP-T) score over all post-dose time points was statistically significantly higher for patients in the amphetamine extended-release tablet group (302.8), compared with the placebo group (279.6). In addition to meeting the primary efficacy endpoint, the study also showed significant gains in PERMP-T scores in patients taking the extended-release amphetamine tablet as early as 0.5 hours post-dose and as late as 13 hours post-dose, compared with placebo.

Investigational ADHD Drug Outperforms Placebo in Adults

The most common adverse events were headache, decreased appetite, irritability, initial insomnia, insomnia, dry mouth, and nausea, and most were mild to moderate in severity. The study found no new adverse reactions.

“The results of this study demonstrate the efficacy of the amphetamine extended-release tablet in treatment of ADHD in adults,” said study principal investigator Andrew J. Cutler, MD, clinical associate professor of psychiatry, State University of New York Upstate Medical University, Syracuse.

“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 post-dose.”

—Jolynn Tumolo

Reference

Tris Pharma presents positive results from phase 3 study of amphetamine extended-release tablet in adults with ADHD [press release]. Monmouth Junction, New Jersey: Tris Pharma Inc.; January 20, 2021.