Akili Interactive announced that it received FDA clearance for its EndeavorRx video game for children with attention deficit hyperactivity disorder (ADHD).
Boston-based Akili’s prescription treatment is delivered through a video game experience to improve attention function as measured by computer-based testing in children between ages 8 and 12 with primarily inattentive or combined-type ADHD.
EndeavorRx received its review through the FDA’s de novo pathway as a treatment designed to directly target and activate neural systems through the presentation of sensory stimuli and motor challenges to improve cognitive functioning, according to a news release.
Clearance was granted based on data from five clinical studies of more than 600 ADHD-diagnosed children. One prospective, randomized, controlled study published in The Lancet Digital Health Journal revealed that EndeavorRx improved objective measures of attention in children with ADHD.
After four weeks of EndeavorRx treatment, one-third of children no longer had a measurable attention deficit on at least one measure of objective attention. About half the parents of children involved saw a clinically meaningful change in day-to-day impairments after one month and that number bumped up to 68% after the second month of treatment.
Akili said EndeavorRx will be available with a prescription soon and will be released as the centerpiece of its Endeavor Care Program that includes the Akili Care mobile tracking app and personal support services for caregivers.
“The clearance of EndeavorRx marks the culmination of nearly a decade of research and development and was fueled by the commitment of our team and collaborators to challenge the status quo of medicine,” Akili senior VP of medical devices Scott Kellogg said in the release. This would not have been possible without the dedication of our clinical research partners and hundreds of families who gave their time and energy to participate in our clinical trials.”