FDA Approves First Video Game-Based Treatment for ADHD

The US Food and Drug Administration has approved the marketing of the first video game-based digital therapeutic device for the treatment of children aged 8 to 12 years with attention deficit hyperactivity disorder (ADHD).

The game, EndeavorRx, can only be accessed with a prescription, and is intended specifically for children with primarily inattentive or combined-type ADHD with demonstrated attention issues. It is both the first digital therapeutic for the improvement of ADHD symptoms and the first game-based therapeutic granted authorization by the FDA for any condition.

It is intended to be used in combination with clinician-directed therapy, medication, and/or educational programs.

The authorization was based upon a review of studies including more than 600 children which used various measures of attention and academic performance and other assessment tools. No serious adverse effects were observed, although frustration, headache, dizziness, emotional reaction, and aggression were common.

—Michael Potts

Reference:

FDA Permits Marketing of First Game-Based Digital Therapeutic to Improve Attention Function in Children with ADHD. News release. FDA; June 15, 2020. https://www.fda.gov/news-events/press-announcements/fda-permits-marketing-first-game-based-digital-therapeutic-improve-attention-function-children-adhd