On Monday, June 15, 2020, the first game-based digital therapeutic device has been permitted for marketing by the U.S. Food and Drug Administration (FDA).
According to the US FDA, the purpose of this prescription-only game-based device is to improve attention function in children with attention deficit hyperactivity disorder (ADHD).
The first-of-its-kind attention treatment is called the EndeavorRx video game. It is indicated for 8 to 12 years old pediatric patients with “primarily inattentive or combined-type ADHD who have demonstrated an attention issue.”
The EndeavorRx is intended for use as part of a therapeutic program which may include clinician-directed therapy, medication, and/or educational programs.
The said program is to 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.”
– Jeffrey Shuren, M.D., J.D., director of the FDA’s Center for Devices and Radiological Health
In addition, Shuren said, “The FDA is committed to providing regulatory pathways that enable patients timely access to safe and effective innovative digital therapeutics.”
Studies about the First Game-Based Prescription
Based on the news release published by the US FDA , they have reviewed data from multiple studies in more than Six Hundred (600) children with ADHD.
This include studies that evaluated whether participants demonstrated improvements in attention function, as measured by the Test of Variables of Attention (TOVA), academic performance measures, and other assessment tools.
Frustration, headache, dizziness, emotional reaction, and aggression are the most common adverse events observed with EndeavorRx. But according to FDA, there were no serious adverse events reported.
The EndeavorRx was reviewed through FDA’s de novo pathway, a regulatory pathway for low- to moderate-risk devices of a new type.
Play Your Medicine – EndeavorRx
The marketing authorization for the EndeavorRx has been granted by the FDA to the Akili Interactive.
And according to Akili, “It’s time to play your medicine.”
“We’re proud to make history today with FDA’s decision. With EndeavorRx, 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. Families are looking for new ways to help their children with ADHD. With today’s decision by FDA, we’re excited to offer families a first-of-its-kind non-drug treatment option and take an important first step toward our goal to help all people living with cognitive issues.”
– Eddie Martucci, Ph.D., chief executive officer of Akili, June 15, 2020
SOURCE
US Food and Drug Administration (FDA)
