The U.S. Food and Drug Administration (FDA) permitted marketing of the first game-based digital therapeutic device to improve attention function in 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. 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 the first game-based therapeutic granted marketing authorization by the FDA for any type of condition. The device is intended for use as part of a therapeutic program that may include clinician-directed therapy, medication, and/or educational programs, which further address symptoms of the disorder.
"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 Jeffrey Shuren, M.D., J.D., director of the FDA's Center for Devices and Radiological Health. "The FDA is committed to providing regulatory pathways that enable patients timely access to safe and effective innovative digital therapeutics."
ADHD is a common disorder that begins in childhood, affecting approximately 4 million children ages 6-11. Symptoms include difficulty staying focused and paying attention, difficulty controlling behavior, and very high levels of activity. According to the Centers for Disease Control and Prevention, diagnosis of ADHD should be conducted by a trained health care professional and follow an evaluation of symptoms or pattern of symptoms, such as inattention, hyperactivity, and impulsivity that interfere with functioning or development.
The FDA reviewed data from multiple studies in more than 600 children, including studies that evaluated, among other things, whether participants demonstrated improvements in attention function, as measured by the Test of Variables of Attention (TOVA), academic performance measures, and other assessment tools. There were no serious adverse events reported. The most common adverse events observed with EndeavorRx are: frustration, headache, 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 FDA granted marketing authorization for the EndeavorRx to Akili Interactive.
About FDA
The FDA, an agency within the U.S. Department of Health and Human Services, protects the public health by assuring the safety, effectiveness, and security of human and veterinary drugs, vaccines and other biological products for human use, and medical devices. The agency also is responsible for the safety and security of our nation’s food supply, cosmetics, dietary supplements, products that give off electronic radiation, and for regulating tobacco products.