Can a video game substitute prescription drugs as a treatment for ADHD? That was the question posed when Akili first submitted its first product, a game to improve attention in children with ADHD, to the FDA in 2018.
Two years later, the Boston-based company received clearance for EndeavorRx to be used as a prescription treatment for ADHD.
“We’re proud to make history today with FDA’s decision, Akili CEO Eddie Martucci said in a news release. “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 approval was granted through the FDA’s de novo pathway, creating a new category of medical devices. It was based on data from five submitted clinical studies, enrolling a total of more than 600 children diagnosed with ADHD.
In 2017, Akili announced it had achieved its primary endpoint in a pivotal study of the treatment. A total of 348 patients participated in the double-blind, randomized, controlled trial.
That year, Akili also showed it was serious with a series of appointments, including former Cubist Pharmaceuticals CEO Rob Perez as executive chairman, and former Dreamworks Interactive CEO Glenn Entis and former Google Chief Game Designer Noah Falstein as advisors.
Just a few months ago, Akili published the results of the study in The Lancet Digital Health: One third of patients that used it for 25 minutes per day no longer had a measurable attention deficit after four weeks of treatment. Half of parents reported a meaningful change in their child’s day-to-day impairments after one month of treatment.
“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,” Scott Kellogg, senior vice president of medical devices at Akili, said in a news 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.”
Aikli said its treatment would be available through a prescription. It hasn’t yet shared a price.