FDA approves EndeavorRx, a prescription treatment for children with ADHD.- Akili

Akili has announced that the FDA has granted clearance for EndeavorRx (AKL-T01) as a prescription treatment for children with attention-deficit/hyperactivity disorder (ADHD).

Delivered through a captivating video game experience, EndeavorRx is indicated to improve attention function as measured by computer-based testing in children ages 8-12 years old with primarily inattentive or combined-type ADHD, who have a demonstrated attention issue. Persistent attention issues have a significant impact on the daily lives of millions of people. Attention impairments are a key component of ADHD for many children yet are often overshadowed by more overt symptoms of ADHD.

EndeavorRx was reviewed through FDA’s de novo pathway and its clearance creates a new class of digital therapeutics. EndeavorRx is designed to directly target and activate neural systems through the presentation of sensory stimuli and motor challenges to improve cognitive functioning..

Using EndeavorRx, patients navigate a character through different worlds while avoiding obstacles and collecting targets to unlock new worlds and receive awards. The captivating experience of ENDEAVOR is designed to drive engagement and compliance.

Comment: This FDA decision is a notable milestone in the FDA’s regulation of digital therapeutics, products that use software to help prevent, manage or treat a range of health conditions. Akili’s product is the first game-based therapeutic FDA has approved for any indication and the first digital therapeutic targeting symptoms associated with ADHD.