Akili, Inc. launches EndeavorOTC digital therapeutic for adult ADHD

Akili, Inc. (Nasdaq: AKLI), a leader in digital therapeutics, has announced a significant breakthrough with the U.S. Food and Drug Administration (FDA) clearance of its latest product, EndeavorOTC (AKL-T01), for adults with attention-deficit/hyperactivity disorder (ADHD). This groundbreaking development marks EndeavorOTC as the first FDA-authorized digital therapeutic for ADHD that is available over the counter. Tailored for adults with primarily inattentive or combined-type ADHD, EndeavorOTC utilizes a novel video game experience designed to improve attention functions.

EndeavorOTC’s FDA approval was supported by a robust clinical trial involving 221 adults diagnosed with inattentive or combined-type ADHD. The study revealed that 83% of participants experienced improved focus as evaluated by the TOVA® attentional control score. Additionally, significant improvements were noted in quality of life and ADHD symptoms, with nearly half of the adults achieving clinically meaningful improvement.

Matt Franklin, CEO of Akili, expressed his pride in this achievement, stating, “This FDA authorization of EndeavorOTC positions it as a scientifically and clinically validated digital therapy for adult ADHD patients. We’re incredibly proud of pioneering a new tier of digital medicine.”

EndeavorOTC is now available for download in the United States on both the Apple App Store and the Google Play Store. It represents a major advancement in the accessibility of treatment options for ADHD, providing users with a unique method to manage their symptoms effectively and independently.

The introduction of EndeavorOTC by Akili is a testament to the company’s commitment to innovation in the digital health space. This product not only meets a significant unmet need but also sets a new standard for treating ADHD without traditional medication. As digital therapeutics continue to evolve, EndeavorOTC is poised to have a considerable impact on how ADHD is treated in adults, offering a non-pharmacological option that fits into everyday life.