The Food and Drug Administration, which handles the review of prescription drugs and therapeutic medical devices in the US, has just approved the first video game intended as part of a therapy regimen for juvenile ADHD. The developer, Akili Interactive, can now officially market their new game EndeavorRX as a treatment for the condition in children ages 8-12.
Akili CEO Eddie Martucci went on record with the following statement, “We’re using technology to help treat a condition in an entirely new way as we directly target neurological function through medicine that feels like entertainment.”
The game’s approval came about through an FDA program called De Novo (not to be confused with Denuvo). The De Novo program establishes a pathway to support for new medical devices with low to moderate risks. The treatment cycle used with EndeavorRX seems reasonably simple: 30 minutes a day, five days a week, for one month. Akili is indicating that repeating the treatment cycle can have increased benefits, though they also recommend a four-week break between periods. It is not something that a parent can simply park their child in front of, though. The game is designed to be part of a comprehensive program that could also include clinical therapy sessions and a medication regimen.
According to the FDA’s press release, there were no serious adverse effects reported during the game’s testing. Common adverse effects were headache, dizziness, emotional reaction, frustration, and aggression. With regards to results, children who were studied as part of the testing process demonstrated marked improvement in attention function using computer-based testing methods.
Director Jeffrey Shuren, of the FDA’s Center for Devices and Radiological Health, had this to say, “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. The FDA is committed to providing regulatory pathways that enable patients timely access to safe and effective innovative digital therapeutics.”