FDA OKs Akili’s EndeavorOTC Video Game for ADHD

Digital therapeutics company Akili has gained U.S. Food and Drug Administration (FDA) clearance for its EndeavorOTC (AKL-T01) over-the-counter (OTC) treatment for adults with attention-deficit/hyperactivity disorder (ADHD).
 
EndeavorOTC is delivered through a video game experience and is indicated to improve attention function, measured by computer-based testing in patients with primarily inattentive or combined-type ADHD with a demonstrated attention issue. It’s the company’s second digital ADHD digital therapeutic to earn FDA authorization, and the only FDA-authorized digital ADHD therapeutic available without a prescription.
 
The clinical study supporting EndeavorOTC’s 510(k) clearance showed 83% of participants reported focus improvement as measured by the TOVA attentional control score. 72.5% of patients reported some quality of life improvement as measured by the Adult ADHD Quality of Life Scale (AAQoL), and nearly 45.8% met a prespecified threshold for clinically meaningful improvement.
 
Akili advised that EndeavorOTC isn’t a replacement for any form of treatment and should be used as part of a therapeutic program that might also include clinician-directed therapy, medication, and/or educational programs.
 
“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, CEO 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.”