BY THEREDNOW STAFF
The US Food and Drug Administration (FDA) has approved a video game that can be used as treatment for attention deficit hyperactivity disorder (ADHD) in children.
The landmark decision permits marketing of the first game-based digital therapeutic device to improve attention functions in children between the ages of eight and 12.
The game, called EndeavorRx and developed by digital medicine company Akili, underwent seven years of clinical trials and requires a prescription which doctors can authorise to be used on an iPhone or iPad.
A video of the game shows a character travelling over a racecourse-like path on a hover board, facing sensory and motor tasks that are designed to help the player improve cognitive functions.
The FDA reviewed data from multiple studies in more than 600 children. They found that there were no serious adverse effects reported. The most common adverse effects observed with EndeavorRx were frustration, headache, dizziness, emotional reaction and aggression.
Speaking to Associated Press, Akili CEO Eddie Martucci said: “We’re proud to make history today with FDA’s decision.
“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.”
Jeffrey Shuren, director of the FDA’s Center for Devices and Radiological Health said: “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.”
According to an FDA press release, EndeavorRx is designed for pediatric patients with primarily inattentive or combined-type ADHD, who have demonstrated an attention issue.
EndeavorRx is indicated to improve attention function as measured by computer-based testing and is the first digital therapeutic intended to improve symptoms associated with ADHD, as well as being the first game-based therapeutic to have been granted marketing authorisation by the FDA, for any type of condition.
ADHD is a common disorder that begins in childhood, affecting approximately four million children ages 6-11. Symptoms include difficulty staying focused and paying attention, difficulty controlling behaviour, and very high levels of activity.