Akili, Inc. announced U.S. Food and Drug Administration (FDA) clearance of EndeavorOTC (AKL-T01) as an over-the-counter treatment for adults with attention-deficit/hyperactivity disorder (ADHD). 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 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 the brain 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.

It is not intended to be used as a stand-alone therapeutic and is not a substitution for a child's medication. The most common side effect observed in children in EndeavorRx's clinical trials was a feeling of frustration, as the game can be quite challenging at times. No serious adverse events were associated with its use.

EndeavorRx is recommended to be used for approximately 25 minutes a day, 5 days a week, over initially at least 4 consecutive weeks, or as recommended by your child?s health care provider.