Dubbed EndeavorOTC, the game comes in the form of a smartphone app and was cleared through the FDA’s 510(k) pathway. Credit: Shutterstock / LaMerce

A phone-based video game designed to treat attention attention-deficit/hyperactivity disorder (ADHD) has been granted market clearance from the US Food and Drug Administration (FDA), marking the first-ever over-the-counter (OTC) video game to be cleared by the authority.

Dubbed EndeavorOTC, the game comes in the form of a smartphone app and was cleared through the FDA’s 510(k) pathway after 83% of patients demonstrated a clinical response to the treatment in a clinical trial.

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The STARS-ADHD-Adult trial (NCT05183919), also found that nearly three-quarters (72.5%) of patients reported at least some improvement in their quality of life (QoL) by way of the Adult ADHD Quality of Life Scale. A further 45.8% of patients met a prespecified threshold for clinically meaningful improvement.

The game, in the infinite runner genre, is available as part of a subscription model and is available on iOS and Android devices.

CEO of Akili, Matt Franklin said: “This FDA authorisation 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.

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“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.”

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The US-based trial enrolled 221 adults with a verified diagnosis of inattentive or combined-type ADHD who all received AKL-T01, the investigational name for the game. The product marks the second of Akali’s digital ADHD therapeutic products to receive FDA clearance.

At the same time the company reports that overall, 11 patients (5%) reported a treatment-emergent adverse device event, most commonly nausea (1.8%) and headache (1.4%), There were no serious adverse device events reported.

The company has also submitted its digital therapeutic SDT-001 for marketing approval with the Japanese Ministry of Health, Labour, and Welfare. Elsewhere in the field of ADHD treatment, German device company Innosphere Engineering has started recruitment for the clinical trial for its electrical stimulation device.