Video Game Treatment for Adults With ADHD Cleared by FDA
The U.S. Food and Drug Administration (FDA) recently cleared digital therapeutic EndeavorOTC (AKL-T01), an over-the-counter treatment for adults with attention-deficit/hyperactivity disorder (ADHD) delivered through a video game experience.
AKL-T01 is indicated for adults with primarily inattentive or combined-type ADHD who have a demonstrated attention issue.
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The study that supported AKL-T01’s clearance showed an improvement in focus in 83% of 221 participants with a verified diagnosis of inattentive or combined-type ADHD, 72.5% reported an improvement in quality of life, and 45.8% met a prespecified threshold for clinically meaningful improvement. In the same study, adults using AKL-T01 showed significant improvement in clinician-rated ADHD symptoms, as measured by the Attention Deficit Hyperactive Disorder Rating Scale-5 (ADHD-RS) inattention subscale and total scale scores (p<0.0001 for both). Of the participants, 32.7% demonstrated at least a 30% reduction in the ADHD-RS total score, surpassing findings in prior studies.
Of the total participants, 11 (5%) reported nausea and headache as a treatment-emergent adverse device event; there were no serious adverse device events reported in the study.
“This FDA authorization of EndeavorOTC positions it as a scientifically and clinically validated digital therapy for adult ADHD patients, and we’re incredibly proud of pioneering a new tier of digital medicine,” said Matt Franklin, chief executive officer at Akili, the digital therapeutics company behind the recent treatment. “This is the culmination of years of clinical studies and the collective effort of scores of technical, scientific, clinical, and regulatory professionals. We are particularly grateful to the patients who participated in the study that made this clearance possible.”
Akili noted that AKL-T01 should not be used as a replacement of any form of treatment and “should be used as part of a therapeutic program that may include clinician-directed therapy, medication, and/or educational programs, which further address symptoms of the disorder.”
