Akili Interactive has received De Novo marketing authorization from the FDA for EndeavorRx, a therapeutic video game for children aged 8-12 years with ADHD (Attention Deficit Disorder/Hyperactivity Disorder).
This is the first authorization that the FDA has granted to a therapeutic video game and also the first authorization for Akili, which has other similar therapeutic products in development.
EndeavorRx is indicated by the agency to improve the symptoms of children associated with ADHDand is intended to be used as part of a broader therapeutic program.
The therapy takes the form of a game in which users navigate an alien avatar through a course while responding to on-screen commands. The app keeps track of movements and can therefore monitor the user’s behavior and quickly adapt to the player.
“We are proud to make history today with the FDA’s decision,” said Eddie Martucci, ECO of Akili, in a statement. “With EndeavorRx, we are using technology to help treat a condition in a whole new way, as we address neurological function directly through a medicine that looks like entertainment. Families are looking for new ways to help their children with ADHD. With today’s decision by the FDA, we are excited to offer families an initial non-pharmacological treatment option and take an important step toward our goal of helping all people living with cognitive problems.”
Akili announced that EndeavorRx will soon be available with a prescription as part of the Endeavor Care Program. This includes, in addition to the therapeutic application, a behavioral monitoring application for parents called ADHD Insight, and a caregiver support hotline called Akili Assist.
EndeavorRx was already distributed by Akili thanks to FDA regulations that allow digital products to be marketed pending official approval.
The FDA said it has reviewed data from multiple studies with over 600 patients – the main one being the STARS-ADHD experimental study that was completed in late 2017 and published just a few months ago.
In this and other studies, the agency has stated that it is seeking clear improvements in the attention function. According to the FDA, no serious adverse events have been reported. Frustration, headaches, dizziness, emotional reactions and aggression have all been reported in the studies as common adverse events.
This authorization paves the way for a new mode of treatment for ADHD that physicians may consider as an alternative or an addition to drug treatments or other therapies.
The De Novo Authorization opens a regulatory path for other digital therapies for ADHD and, more generally, sets a precedent for game-based products as evidence-based and controlled treatments.