Tris Pharma Presents Positive Results from Phase 3 Study of Amphetamine Extended-Release Tablet in Adults with ADHD
- Study met primary endpoint measure of sustained attention in adults with ADHD
- Showed statistically significant improvement vs. placebo in mean PERMP-Total score measured from 0.5 hours to 14 hours post-dose
- No new adverse reactions reported during the study
MONMOUTH JUNCTION, NJ, January 20, 2021 / PRNewswire/ – Tris Pharma, Inc. (“Tris”), a specialty pharmaceutical company with a robust portfolio of approved products and a late-stage pipeline of innovative product candidates for the treatment of Attention Deficit Hyperactivity Disorder (ADHD) and related disorders, today announced that it presented data from a pivotal efficacy and safety study on its new amphetamine extended-release tablet at the virtual annual meeting of American Professional Society of ADHD and Related Disorders (APSARD), January 15 – 17, 2021.
Results from the study, entitled “Randomized, Double-Blind, Placebo-Controlled, Fixed-Dose Study to Evaluate the Efficacy and Safety of the Amphetamine Extended-Release Tablet in Adults with Attention-Deficit/Hyperactivity Disorder,” were reported during the annual APSARD meeting. The study was designed to evaluate the efficacy and safety of amphetamine extended-release tablets in adults aged 18-60 years with ADHD compared with placebo.
The primary efficacy endpoint was met: the mean Permanent Product Measure of Performance total (PERMP-T) score over all post dose time points was statistically significantly higher in the amphetamine extended-release tablet group compared with placebo (302.8 vs 279.6; p=0.0043). Additionally, statistically significant improvements (increase) in PERMP-T scores were observed in the amphetamine extended-release tablet group as early as 0.5 hours (p=0.0115) and as late as 13 hours (p=0.0056) post dose compared with placebo. Most common adverse events included headache, decreased appetite, irritability, initial insomnia, insomnia, dry mouth, and nausea. Most treatment-emergent AEs (TEAEs) were mild to moderate in severity, and no SAEs were reported during the study.
Amphetamine extended-release tablet is an investigational agent and is not currently approved for use in any country. It is currently under review at the U S Food and Drug Administration
“The results of this study demonstrate the efficacy of the amphetamine extended-release tablet in treatment of ADHD in adults,” said Andrew J. Cutler, MD, Clinical Associate Professor of Psychiatry, SUNY Upstate Medical University and the principal investigator of the study. “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.”
About Tris Pharma
Tris Pharma is a New Jersey-based specialty pharmaceutical company focused on the development and commercialization of innovative medicines that address unmet patient needs. Tris has used its LiquiXR technology platform to develop a portfolio of differentiated solid and liquid medications as well as a robust pipeline which spans multiple therapeutic categories, and its technology has formed the basis for numerous mutually value-adding development partnerships. Within the United States Tris promotes its portfolio of ADHD products (described at www.TrisADHD.com) using its pediatric and CNS-focused sales force. For more information, please visit staging.trispharma.com
Pardo A, Kando JC, King TR, Rafla E, Herman BK. Single dose pharmacokinetics of amphetamine extended release tablets compared with amphetamine extended release oral suspension. CNS Spectr . 2020 Jan 22:1 8. doi : 10.1017/S1092852919001676. Epub ahead of print. PMID: 31964449.
Pardo A, King TR, Rafla E, Everitt A, Kando JC. Palatability Assessment of a New Amphetamine Extended Release Tablet Formulation. Virtual platform presentation delivered at the 2020 AACAP Annual Meeting, 23 October 2020.
Cutler AJ, Pardo A, King TR, Rafla E, Duhoux S, and Kando JC. Randomized, Double Blind, Placebo Controlled, Fixed Dose Study to Evaluate the Efficacy and Safety of the Amphetamine Extended Release Tablet in Adults with Attention Deficit/Hyperactivity Disorder. Virtual poster presentation delivered at the 2021 APSARD Annual Meeting, January 15, 2021.