ADHD-treating video game to chart FDA approval path

Akili Interactive Labs has developed a video game it says can treat ADHD. Now for the tricky part: getting FDA approval.

"Project Evolution," the company's game, is designed to hone players' visual attention, piggybacking on research that suggests playing action games can improve prefrontal cortex function. The game, developed for mobile devices, is designed to strengthen the visual and motor parts of the brain, training players to concentrate without the use of drugs like Adderall and Ritalin.

Next up is a filing with the FDA. As a mobile health app, "Project Evolution" will have to go through the agency's Center for Devices and Radiological Health, much like a medical device. However, its future application will be a first for the FDA. While the agency has vetted and cleared a few diagnostic apps, the game--if approved--would be the first therapeutic app cleared in the U.S., Akili co-founder Eric Martucci told FierceMedicalDevices.

"We are expecting that this will be new ground to break as we move through this process," Martucci said in an email. And while Martucci declined to discuss the company's plans for regulatory filing in detail, it's worth noting that Akili hasn't taken the game straight to an app store, like iTunes, and is instead seeking the agency's OK. What remains to be seen is whether the company will file for 510(k) clearance or full pre-market approval.

Akili, a company launched by PureTech Ventures, wants the game to provide efficacy and tolerability beyond available treatments, the firm told The Wall Street Journal. And unlike the current crop of stimulants prescribed to treat ADHD, "Project Evolution" wouldn't carry the risk of anxiety and trouble sleeping.

If all goes according to plan, the game will be a treatment option for doctors and patients before they turn to traditional medications, Akili told the paper, and, in the process, a new field of therapeutic apps could be created.

- get more from the WSJ (sub. req.)

CORRECTION: An earlier version of this story said that Brain Plasticity worked with Akili on the game. Brain Plasticity is in fact developing separate computerized excercises. We regret the error.