Akili has received clearance from the U.S. Food and Drug Administration (FDA) for EndeavorRx as a prescription treatment for children with attention-deficit/hyperactivity disorder (ADHD).
Delivered through a 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.
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.
Eddie Martucci, chief executive officer of Akili, said: “With EndeavorRx, we’re using technology to help treat a condition in an entirely new way as we directly target neurological function through medicine that feels like entertainment. Families are looking for new ways to help their children with ADHD. With today’s decision by FDA, we’re excited to offer families a first-of-its-kind non-drug treatment option and take an important first step toward our goal to help all people living with cognitive issues.”
EndeavorRx was granted clearance based on data from five clinical studies in more than 600 children diagnosed with ADHD, including a prospective, randomised, controlled study published in The Lancet Digital Health journal, which showed 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. Approximately half of parents saw a clinically meaningful change in their child’s day-to-day impairments after one month of treatment with EndeavorRx; this increased to 68% after a second month of treatment. Improvements in ADHD impairments following a month of treatment with EndeavorRx were maintained for up to a month.
Elysa Marco, cognitive and behavioural child neurologist and clinical executive for neurodevelopmental medicine at Cortica Healthcare, said: "For children living with ADHD, improving their ability to focus and resist distraction is critical to their daily functioning and performance in school. Unlike traditional ADHD medications, EndeavorRx is designed to specifically target inattention. Based on the benefits my research participants and patients have experienced, I am thrilled that EndeavorRx is moving from the lab to the clinic to play an essential role as part of a comprehensive treatment plan for children with ADHD.”
The EndeavorRx treatment will be available with a prescription to families soon, and will be released as the centrepiece of the Endeavor Care Program, which includes the EndeavorRx treatment and Akili Care, a mobile tracking app and personal support services for caregivers.
