How the first-ever digital ADHD treatment—a video game—got the FDA’s blessing

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Depending on whose numbers you use, somewhere between 5{ce8ce7cc98bffdc4302011057a79600ea02c464c5536f1477c12acdb8bd79c00} and 11{ce8ce7cc98bffdc4302011057a79600ea02c464c5536f1477c12acdb8bd79c00} of American children have ADHD (attention deficit hyperactivity disorder). That has created a massive market for attention deficit disorder drugs such as Adderall, Ritalin, Vyvanse, and others.

But those treatments are all traditional therapeutics, imbibed via pills. Now, a digital competitor is heading into the space—a prescription video game that’s meant to help children with ADHD focus.

The product is Boston-based digital health firm Akili’s EndeavorRx, and it’s the first of its kind to gain Food and Drug Administration (FDA) clearance. Akili has been around since 2010 but walked a very specific path to get to this milestone.

“Everything is about data,” Akili CEO Eddie Martucci tells Fortune. “Getting the clinical evidence, so people can trust it. And by that I mean the patients, their doctors, everyone.”

The focus on evidence and data is built into Martucci’s academic pedigree. He has a Ph.D. in biochemistry and biophysics from Yale and then headed into the world of health entrepreneurship. “I’ve always been interested in letting the science be done by the researchers and then bring it to patients,” he says.

And therein lies the secret sauce to Akili’s success with the FDA. The digital health realm is littered with bold proclamations which often don’t pan out. Martucci’s philosophy is that the tech and the hype must always be supplemented by evidence in the real world via the means of randomized trials.

“We’ve worked with investors in both the technology field and the health care field. Our board is a hybrid of those two [forms of] expertise,” he says. “We partner with top-tier universities, such as UC–San Francisco, Duke University, and countless others to run rigorous clinical trials.” The company also has strategic partnerships with companies such as Japanese drug giant Shionogi to market its product.

Akili has conducted five clinical studies involving more than 600 children with ADHD. These included randomized controlled trials—considered the gold standard in the clinical study world—which place different study participants into various groups to see whether or not one therapeutic approach is as effective as another.

Martucci emphasizes that the video game approach isn’t meant to supplant traditional drugs. He considers it a targeted digital treatment to increase focus and says the company’s studies have shown the product is just as good on that front for patients who take ADHD medications as well as for those who don’t.

“We’re not focused on just shoving this into some existing pharmaceutical model,” he says. “We want this to be what the model for digital therapeutics actually should be.”

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