On Monday, the U.S. Food and Drug Administration (FDA) permitted the first therapeutic video game designed to improve the attention function in children with attention deficit hyperactivity disorder, commonly known as ADHD.
This is the first time a game-based therapeutic device earned FDA approval for any condition.
The game, called EndeavorRX and made by Akili Interactive, is meant for children ages 8 to 12 years old who have been diagnosed with primarily inattentive or combined-type ADHD, according to the press release. Studies have shown EndeavorRX can improve attention function and other symptoms associated with ADHD. The prescription-only game is meant to be used as a supplement for other clinician-directed therapies or medication.
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“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,” Jeffrey Shuren, director of the FDA’s Center for Devices and Radiological Health, said in the prepared statement. “The FDA is committed to providing regulatory pathways that enable patients timely access to safe and effective innovative digital therapeutics.”
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Pursuant to marketing approval, the FDA reportedly reviewed data from studies conducted with more than 600 children as measured by the Test of Variables of Attention (TOVA) and academic performance indicators. Additionally, no serious side effects were reported.
The most common reported adverse effects included headaches, dizziness and emotional frustration.
EndeavorRx was reviewed through the FDA’s De Novo premarket review pathway, which is a regulatory channel for low-risk devices.
The game had been awaiting review from the FDA since mid-2018, according to STAT News. The FDA did not say whether or not the coronavirus pandemic impacted the approval.
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