Akili announces FDA authorization of EndeavorOTC

Akili announced U.S. Food and Drug Administration clearance of EndeavorOTC as an over-the-counter treatment for adults with attention-deficit/hyperactivity disorder. Delivered through an engaging 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 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. “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. “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.”