The US Food and Drug Administration (FDA) has approved the first video game for treating children with attention deficit hyperactivity disorder (ADHD).
“The prescription-only game-based device, called EndeavorRx, is indicated for pediatric patients ages 8 to12 years old with primarily inattentive or combined-type ADHD who have demonstrated an attention issue,” the agency said Monday in a press release.
The iPhone and iPad game is intended for use as part of a therapeutic program that may include clinician-directed therapy, medication or educational programs.
Jeffrey Shuren, director of the FDA’s Center for Devices and Radiological Health, hailed EndeavorRx as “a non-drug option” for improving symptoms associated with ADHD.
“The FDA is committed to providing regulatory pathways that enable patients timely access to safe and effective innovative digital therapeutics,” he said in the same release.
ADHD, a common disorder that begins in childhood, impacts nearly 4 million children aged 6-11. Symptoms include difficulty staying focused and paying attention, difficulty controlling behavior and very high levels of activity.
The health agency said it reviewed data from multiple studies in more than 600 children to see whether participants demonstrated improvements in attention function by playing the game. There were no serious side effects reported.
“The most common adverse events observed with EndeavorRx are frustration, headache, dizziness, emotional reaction and aggression,” it added.
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