A Video Game Prescription for ADHD? FDA Approves First-Ever Game-Based Therapy for Attention
Akili Interactive’s EndeavorRx is the first game-based digital therapeutic device approved by the FDA for the treatment of attention function in children with ADHD. The history-making FDA OK followed a limited-time release of the device during the coronavirus pandemic, and several years of testing the device in randomized controlled trials.
June 18, 2020
A prescription-only video game called EndeavorRx has been approved by the Food and Drug Administration (FDA) to treat attention functioning in patients with attention deficit hyperactivity disorder (ADHD).1 Developed by Akili Interactive, this is the first game-based digital therapeutic device to receive marketing and prescription authorization by the FDA for any type of condition. An emergency release of EndeavorRx was authorized by the FDA in April in response to the pandemic.
EndeavorRx is approved for children 8 to 12 years old with primarily inattentive or combined-type ADHD; it is an iPhone and iPad game that promises to improve attention function, as measured by computer-based testing. The video game is not meant to replace traditional ADHD treatments, namely medications and behavioral therapy.
Akili CEO Eddie Martucci says it is a targeted digital treatment that increases focus for patients who take ADHD medications and for those who don’t, according to company research.2 This research showed that one-third of children experienced improvement on at least one measure of objective attention after using EndeavorRX for up to 25 minutes per day, five days a week, for four weeks or more. Common side effects were headache and frustration.
Akili has been working toward FDA approval for several years. The treatment has been evaluated in more than 600 children with ADHD across five clinical studies. These included randomized controlled trials, which are considered a gold standard in the clinical study world and likely contributed to EndeavorRx becoming the first video game to receive FDA approval for improving attention function in children with ADHD.3
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1FDA Permits Marketing of First Game-Based Digital Therapeutic to Improve Attention Function in Children with ADHD (Jun. 2020) https://www.fda.gov/news-events/press-announcements/fda-permits-marketing-first-game-based-digital-therapeutic-improve-attention-function-children-adhd
2Mukherjee, Sy. How the first-ever digital ADHD treatment—a video game—got the FDA’s blessing. Fortune (Jun. 2020). https://fortune.com/2020/06/17/digital-adhd-treatment-fda-akili/
3Mukherjee, Sy. How the first-ever digital ADHD treatment—a video game—got the FDA’s blessing. Fortune (Jun. 2020). https://fortune.com/2020/06/17/digital-adhd-treatment-fda-akili/