In multiple clinical trials, investigators do not find any serious adverse events.
The US Food and Drug Administration (FDA) is allowing the first game-based digital therapeutic device aimed at improving attention function in children with attention deficit hyperactivity disorder (ADHD) to move forward.
The decision allows doctors to prescribe EndeavorRx, produced by Akili Interactive, to pediatric patients between 8-12 with primarily inattentive or combined-type ADHD who have demonstrated an attention issue.
The digital game is designed to improve attention function as measured by computer-based testing and is intended to use as part of a therapeutic program that could include clinician-directed therapy, medication, and/or educational programs.
The approval is based on an FDA review from multiple studies in more than 600 children, including studies that evaluated whether participants demonstrated improvements in attention function, measured by the Test of Variables of Attention (TOVA), academic performance measures, and other assessment tools.
There were no serious adverse events reported, with the most common adverse events being frustration, headaches, dizziness, emotional reaction, and aggression.
The FDA reviewed the EndeavorRx through the De Novo premarket review pathway, a regulatory pathway for low- to moderate-risk devices of a new type.
This action creates a new regulatory classification, which means that subsequent devices of the same type with the same intended use may go through the FDA's 510(k) premarket notification process, whereby devices can obtain marketing authorization by demonstrating substantial equivalence to a predicate device.
"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," Jeffrey Shuren, MD, JD, director of the FDA's Center for Devices and Radiological Health, said in a statement. "The FDA is committed to providing regulatory pathways that enable patients timely access to safe and effective innovative digital therapeutics."
ADHD impacts approximately 4 million children in the US between 6-11 years old.