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FDA Approves First-Ever Treatment Video Game for Kids With ADHD

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Update: On June 15, the Food and Drug Administration (FDA) approved Akili’s video game treatment for ADHD. It’s the first time a video game has ever been FDA approved as a treatment. The game, now called EndeavorRx, was initially released for free prior to approval during the COVID-19 pandemic. “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, in a press release. 

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A prescription technology company announced it would make its ADHD attention-therapy game, Endeavor, available to families for free during the COVID-19 pandemic. The game was released under relaxed Food and Drug Administration (FDA) guidelines to deliver services to kids at home because of COVID-19 stay-at-home orders.

Created by Akili Interactive, a “prescription digital medicine company,” Endeavor is a video game treatment program for kids with attention deficit hyperactivity disorder (ADHD). A form of neurodiversity, people with ADHD process sensory stimulation differently than typical kids, and may experience inattention, hyperactivity and distractibility. Many people on the autism spectrum or with sensory processing issues are also diagnosed with ADHD.

Endeavor was designed to help strengthen attention in kids between the ages of 8-12 years old. It operates like any other video game, where kids must navigate their character through different worlds and unlock new items and challenges. It’s designed to be played in 30-minute intervals daily in one-month cycles as part of a larger support protocol designed by Akili. Five clinical trials suggested the game helped increase attention with few risks.

Akili is working to get Endeavor approved by the FDA as part of an official, non-medication treatment protocol that would require a prescription. However, Akili announced a launch prior to FDA approval under the agency’s relaxed guidelines for low-risk “digital health therapeutic devices for psychiatric disorders” during the COVID-19 pandemic. The FDA’s guidelines are designed to help deliver supportive services to kids who are at home during the pandemic.

“At Akili, we’ve been steadfast in our commitment to build a future where effective medicine is not only easily accessible but also can treat patients in an entirely new and engaging way,” Eddie Martucci, Ph.D., chief executive officer of Akili, said in a press release. “During this time of increased need, we’re proud to be able to immediately offer our new clinically validated digital medicine experience to the ADHD community.”

Parents who want to gain access to Endeavor for their kids are encouraged to reach out to their child’s health care provider first. You can then request access to the game through Endeavor’s website, which Akili is offering for free without a prescription for 90 days. Currently, the game is only available in the United States on iOS devices.

Header image via Business Wire/Akili Interactive

Originally published: April 23, 2020
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