EndeavorRx, Akili's video game therapeutic, receives FDA De Novo clearance
EndeavorRx, Akili's video game therapeutic, receives FDA De Novo clearance
EndeavorRx, Akili's video game therapeutic, receives FDA De Novo clearance
By Dave Muoio
June 15, 2020
Summary
After years of waiting, Akili Interactive has finally received FDA De Novo marketing authorization for EndeavorRx, its video-game digital therapeutic for children aged 8 to 12 years with ADHD. This is the first game-based therapeutic that the FDA has greenlit for any condition, the regulatory agency noted in its announcement.
Previously known as Project: Evo and AKL-T01, the EndeavorRx software treatment is indicated by the agency to improve children's symptoms associated with ADHD, and is intended for use as one component of a broader therapeutic program addressing these symptoms.
The therapeutic takes the form of a game in which users navigate an alien avatar through a course while they respond to on-screen prompts.
Akili said in the statement that EndeavorRx "Will be available with a prescription to families soon" as part of the company's Endeavor Care Program, which includes, alongside the therapeutic app, a behavior-tracking app for parents called ADHD Insight and a direct line to caregiver support services called Akili Assist.
A nonprescription form of the digital therapeutic is already being distributed by the company thanks to an emergency policy from the FDA allowing digital products for to be temporarily released before a more formal approval.
The data and the De Novo clearance pave the way for a new modality of ADHD treatment that clinicians can consider as an alternative, or addition to, drug-based treatments and other efforts.
"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," Dr. Jeffrey Shuren, director of the FDA's Center for Devices and Radiological Health, said in a statement.
Beyond the benefits of EndeavorRx itself, the De Novo clearance opens up a regulatory pathway for upcoming software therapies for ADHD, and more broadly sets a precedent for game-based products as vetted, evidence-based treatments.
In January of 2019, Martucci drew a line in the sand separating Akili from the broader trend of digital therapeutics companies partnering with established pharmas to distribute their products.
The De Novo clearance is a feather in the cap for Akili, which was already recognized within the digital therapeutics space as a frontrunner in video game medical treatments, but it's not the only company combining biofeedback and games to drive behavioral health treatments.
Reference
Muoio, D. (2020, June 15). EndeavorRx, Akili's video game therapeutic, receives FDA De Novo clearance. Retrieved June 17, 2020, from https://www.mobihealthnews.com/news/endeavorrx-akilis-video-game-therapeutic-receives-fda-de-novo-clearance