FDA Approves First Ever Video Game to Treat ADHD

SAN ANGELO, TX – For the first time in its history the Food and Drug Administration has approved a video game-based treatment for children who have attention deficit hyperactivity disorder or ADHD.

According to the FDA, the video game was approved on Monday and will only be available with a prescription. The game is called EndeavorRx and is supposed to improve attention function as measured by computer-based testing and is the first digital therapeutic intended to improve symptoms associated with ADHD.

The game, which is aimed at children ages 8-12, will be used along with additional treatments such as clinician-directed therapy, medication, and educational programs.

According to the FDA, EndeavorRx is the first game-based therapy that is granted marketing authorization.

"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 Dr. Jeffrey Shuren, director of the FDA's Center for Devices and Radiological Health.

Approximately four million children, ages 6-11, are affected by ADHD during their childhood. Diagnosing ADHD requires an evaluation of multiple symptoms or patterns of symptoms.

Symptoms of ADHD include:

• Difficulty staying focused
• Paying attention
• Difficulty controlling behavior
• Very high levels of activity.

In multiple studies of more than 600 children “no serious adverse events [were] reported.” 

The most common adverse events observed with EndeavorRx are frustration, headache, dizziness, emotional reaction, and aggression.