Akili Interactive’s Video Game for ADHD Gets the FDA All Clear

Xconomy Boston — 

The newest attention deficit hyperactivity disorder (ADHD) treatment comes with instructions unlike any other therapy: Press “PLAY.”

Akili Interactive was awarded FDA clearance on Monday for EndeavorRx, a “digital therapeutic” developed to treat ADHD through a video game experience. The regulatory decision makes the Boston company’s product the first prescription therapy that comes in the form of a video game.

To a child playing EndeavorRx (screenshot above), the experience is similar to many quest-type video games. A child controls a character navigating a fantasy world on a hover board. That character must stay on course while steering clear of fire, flying objects, and other distractions or obstacles. The experience is intended to improve a child’s ability to pay attention and stay on task.

Underpinning the engaging onscreen imagery is Akili’s core technology, called the Akili Selective Stimulus Management Engine. The company says this technology is designed to target and activate neural systems to improve cognitive function. The more a child plays, the more attuned the game becomes to his or her behavior. Adaptive algorithms personalize the gaming experience to each child. Consequently, EndeavorRx constantly challenges players, encouraging them to improve.

ADHD affects an estimated 4 million children, according to the Centers for Disease Control and Prevention. FDA clearance for EndeavorRx covers children ages 8 to 12 who are diagnosed with the primarily inattentive form of ADHD, as well as those who have a combined form of the disorder that’s characterized by inattentiveness as well as impulsive behaviors. The agency based its decision on five clinical trials enrolling more than 600 patients. The results showed that after four weeks of treatment, at least one measurable attention deficit was no longer apparent. The benefit also translated to family life. About half of patients’ families reported a clinically meaningful change in their child’s day-to-day impairment after one month. That percentage increased to 68 percent after two months. Full results were published in February in The Lancet Digital Health.

In a prepared statement, Jeffrey Shuren, the director of the FDA’s Center for Devices and Regulatory Health, said the Akili game offers children who have ADHD a non-drug option for their treatment. He added that the agency is “committed to providing regulatory pathways that enable patients timely access to safe and effective innovative digital therapeutics.”

This spring Akili made its game available on a limited basis, based on new FDA guidance supporting the use of new digital technologies for treating psychiatric disorders in light of the COVID-19 outbreak. Speaking last month at Xconomy’s Xcelerating Life Sciences Boston event, Akili CEO Eddie Martucci said that the pandemic is creating a “new normal” in which patients and clinicians are looking for alternatives to pills. “There’s an urgent need for digital tech that wasn’t there a few months ago,” he said.

Akili did not specify a launch date for EndeavorRx, other than to say it would be “soon.” But the company says the game will be the centerpiece of a program that includes a mobile tracking app and support services for a child’s caregivers. The company adds that its game should be part of a broader approach to ADHD that may include therapy, medication, and educational programs. When the game launches, it will be available by download to a mobile device and will not require any other special equipment.

Akili’s technology is based on research that started at the University of California, San Francisco. The startup incubated within PureTech Health. Here’s more on the origins of Akili and its approach to video game therapies.

Photo by Businesswire