The US Food and Drug Administration (FDA) has cleared a video game as a prescription treatment for children with attention-deficit/hyperactivity disorder (ADHD). Maker Akili Interactive said its EndeavorRx clearance creates a new class of digital therapeutics.
“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,” Akili chief executive officer Eddie Martucci, PhD, said.
Reviewed through the FDA’s de novo pathway, EndeavorRx is indicated to improve attention function, as measured by computer-based testing, in children aged 8 to 12 years with primarily inattentive or combined-type ADHD and a demonstrated attention issue.
FDA clearance was based on data from 5 clinical studies spanning more than 600 children with ADHD that showed EndeavorRx improved objective measures of attention. One-third of children no longer had a measurable attention deficit on at least one measure of objective attention after 4 weeks of use, Akili reported.
In addition, nearly 50% of parents reported a clinically meaningful change in their child’s day-to-day impairments after 1 month of use. After a second month, the proportion increased to 68%. Improvements after a month of EndeavorRx treatment were maintained for up to 1 month.
EndeavorRx will be available with a prescription and will be released as the centerpiece of the Endeavor Care Program, which includes the EndeavorRx treatment and a mobile tracking app and personal support services for caregivers, according to Akili. EndeavorRx does not require equipment other than a mobile device.
“Families are looking for new ways to help their children with ADHD,” Dr. Martucci said. “We’re excited to offer families a first-of-its-kind nondrug treatment option and take an important first step toward our goal to help all people living with cognitive issues.”