The FDA Just Approved a Prescription Video Game

Anyone who’s ever pulled a Mountain Dew-fueled all-nighter with a controller in their hand knows that, like drugs, video games can be addictive. But now it appears that, like drugs, they might also be useful in treating specific medical conditions.

For the first time, the Food and Drug Administration just approved a prescription-only “game-based digital therapeutic device,” what the rest of us might call a medicinal video game.

EndeavorRx, the game itself, looks like a pretty simple 3D game in which players pilot a vehicle around a course, trying to dodge obstacles and avoid targets. But Akili, the prescription digital medicine company behind the game, can now market the iPhone and iPad game as an effective tool in improving attention function in kids aged 8-12 years old who have an attention issue stemming from ADHD.

“The EndeavorRx device offers a non-drug option for improving symptoms associated with ADHD in children and is an important example of the growing field of digital therapy and digital therapeutics,” said Jeffrey Shuren, M.D., J.D., director of the FDA’s Center for Devices and Radiological Health.

The FDA based its decision on multiple studies in more than 600 children, at least one of which was funded by Akili. The found a marked improvement in scores on the Test of Variables of Attention Attention Performance Index in kids who played the game, with minor side effects like headache and frustration that pale in comparison to those of traditional ADHD medications.

But lest you think that all kids with ADHD need to do is play a video game for 25 minutes a day, even the Akili-funded study concluded that a video game should not “be used as an alternative to established and recommended treatments for ADHD.” As such, the FDA approved EndeavorRx “as part of a therapeutic program that may include clinician-directed therapy, medication, and/or educational programs.”

Akili made EndeavorRx available to a limited number of patients under the FDA’s relaxed COVID-19 enforcement discretion guidance back in April, but this new approval means it can start marketing the treatment more broadly. If you think your kid might benefit, you can sign up for a waitlist on Akili’s website.

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