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Boston-based Akili announced that the U.S. Food and Drug Administration (FDA) had approved its EndeavorRx as a prescription therapy for children with attention deficit hyperactivity disorder (ADHD). What’s unusual about this is that EndeavorRx is delivered via a video game, EndeavorRx.
The game has been proven to improve attention as measured by computer-based testing in kids ages 8 to 12 who have primarily inattentive or combined-type ADHD and have shown attention issues. The game was reviewed through the agency’s de novo pathway and as a result, creates a new class of digital therapeutics.
“We’re proud to make history today with FDA’s decision,” said Eddie Martucci, chief executive officer of Akili. “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.”
The company conducted five clinical trials in more than 600 children diagnosed with ADHD. One of those trials was a prospective, randomized, controlled study published in The Lancet Digital Health journal. The published study noted that ADHD is a common pediatric neurodevelopmental disorder and that alternatives to traditional care, such as novel digital therapeutics, have shown promise in remediating cognitive deficits linked to the disorder and might help alleviate some of the issues of standard therapies, like drugs and behavioral therapy.
EndeavourRx (AKL-T01), they wrote in the study, “is an investigational digital therapeutic designed to target attention and cognitive control delivered through a video game-like interface via at-home play for 25 minutes per day, 5 days per week for 4 weeks.”
Between July 15, 2016, and November 30, 2017, they evaluated 857 patients, with 348 using the gaming system and the rest were a control group. In the study, EndeavorRx demonstrated a statistically significant improvement compared to an educational-style video game control on a change in the Attention Performance Index (API) of the Test of Variables of Attention (TOVA), an FDA-cleared computerized test to evaluate the effects of ADHD interventions.
No serious adverse events were observed. Some of the children in the study, about 9.3%, experienced non-serious side effects, including frustration, headache, dizziness, emotional reaction, nausea or aggression.
EndeavorRx utilizes the company’s Akili Selective Stimulus Management engine (SSME) core technology that is designed to target activation of specific neural systems in the brain to treat illnesses with associated cognitive dysfunction. It presents specific sensory stimulation and simultaneous motor challenges that target and activate the specific neural system that are involved in attention function while also leveraging adaptive algorithms to personalize treatment for each patient.
“For children living with ADHD, improving their ability to focus and resist distraction is critical to their daily functioning and performance in school,” said Elysa Marco, cognitive and behavioral child neurologist and Clinical Executive for Neurodevelopmental Medicine at Cortica Healthcare. “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 company says it expects EndeavorRx to be available with a prescription to families soon. It will be released as the centerpiece of the Endeavor Care Program, which includes EndeavorRx and Akili Care, a mobile tracking app and personal support services for caregivers. EndeavorRx will be downloaded from the App Store onto mobile devices and does not require additional equipment.