Akili, a digital therapeutics company, announced FDA clearance of EndeavorOTC (AKL-T01) as an over-the-counter treatment for adults with attention-deficit/hyperactivity disorder (ADHD). Delivered through an video game experience, EndeavorOTC is indicated to improve attention function as measured by computer-based testing in men and women with primarily inattentive or combined-type ADHD, who have a demonstrated attention issue.
EndeavorOTC is Akili’s second digital ADHD therapeutic product to receive FDA authorization, and the company said it is the only FDA-authorized digital therapeutic for ADHD available without a prescription. EndeavorOTC is currently available in the United States on the Apple App Store for iOS and the Google Play Store for Android mobile devices.
EndeavorOTC was reviewed and cleared through FDA’s 510(k) pathway. The clinical study supporting EndeavorOTC’s FDA clearance involved 221 adults with a verified diagnosis of inattentive or combined-type ADHD who all received AKL-T01 (the investigational name for EndeavorOTC and EndeavorRx) for 6 weeks. Overall, 83% of study participants reported improvement in focus as measured by the TOVA attentional control score. Nearly three-quarters (72.5%) of participants reported at least some improvement in their quality of life as measured by the validated Adult ADHD Quality of Life Scale (AAQoL), and nearly 50 percent (45.8%) of adults met a prespecified threshold for clinically meaningful improvement.
In the same study, adults using AKL-T01 also 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). A prespecified responder analysis also showed that 32.7% of all participants in the study demonstrated at least a 30% reduction on the ADHD-RS total score, surpassing findings in the prior STARS-ADHD-Adolescents study in 13-17 year olds with ADHD (27.1%) and the STARS-ADHD study in 8-12 year olds with ADHD (24%)—and the latter two studies led to the FDA’s authorization of our pediatric and clearance of adolescent product, EndeavorRx. Overall, 11 of the participants in the trial (5%) reported a treatment-emergent adverse device event, most commonly nausea (1.8%) and headache (1.4%). There were no serious adverse device events.
