The American 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 paediatric patients ages 8 to 12 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 authorisation 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. The FDA is committed to providing regulatory pathways that enable patients timely access to safe and effective innovative digital therapeutics.”Jeffrey Shuren, M.D., J.D., director of the FDA’s Center for Devices and Radiological Health
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 behaviour, 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.