Akili has received the US Food and Drug Administration (FDA) clearance for EndeavorOTC (AKL-T01) in adults with attention-deficit/hyperactivity disorder (ADHD).

EndeavorOTC is an over-the-counter digital therapeutic designed to enhance attention function, assessed through computer-based testing, by using a video game experience.

It is indicated for individuals aged 18 and above diagnosed with primarily inattentive or combined type ADHD, and who exhibit attention issues.

The therapy is Akili’s second FDA-authorised digital therapeutic for ADHD. Its prescription-based EndeavorRx therapy was approved in June 2020 to treat paediatric ADHD individuals.

EndeavorOTC is said to be the only FDA-approved non-prescription option available for ADHD.

It is currently accessible in the US via the Apple App Store for iOS and the Google Play Store for Android mobile devices.

Akili CEO 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.

“This is the culmination of years of clinical studies and the collective effort of scores of technical, scientific, clinical, and regulatory professionals.”

The approval was based on a clinical trial that involved 221 adults diagnosed with inattentive or combined-type ADHD, who used AKL-T01 for six weeks.

Results showed that 83% of participants reported improved focus based on the TOVA attentional control score.

Additionally, 72.5% of enrolled patients demonstrated some enhancement in quality of life measured by the Adult ADHD Quality of Life Scale (AAQoL), while 45.8% achieved clinically meaningful improvement.

In terms of ADHD symptoms, participants using AKL-T01 showed significant improvements in clinician-rated ADHD symptoms, as measured by the Attention Deficit Hyperactive Disorder Rating Scale-5 (ADHD-RS) inattention subscale.

Furthermore, a prespecified analysis revealed that 32.7% of participants experienced at least a 30% reduction in the ADHD-RS total score, surpassing findings from prior studies involving EndeavorRx.

Recently Akili signed a merger deal with Virtual Therapeutics to establish a major digital health company.

The combined entity will operate as Virtual Therapeutics, a privately held firm, with Akili as its wholly owned subsidiary.