Akili Gets FDA Clearance for ADHD Video Game Over-the-Counter Treatment

Dow Jones06-19

By Sabela Ojea

Akili said that EndeavorOTC has been authorized by the Food and Drug Administration as an over-the-counter treatment for adults with attention-deficit/hyperactivity disorder through a video game experience.

The prescription digital medicine company said that the FDA clearance positions EndeavorOTC as a scientifically and clinically validated digital therapy for adult ADHD patients.

In a clinical study, 83% of study participants reported improvement in focus as measured by the test of variables of attention (TOVA) control score.

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, the company added.

Write to Sabela Ojea at sabela.ojea@wsj.com; @sabelaojeaguix

(END) Dow Jones Newswires

June 18, 2024 16:20 ET (20:20 GMT)

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