UPDATE June 22, 2020: Last week, the FDA cleared a prescription-only version of the game, EndeavorRx. This marks the first time that a game-based digital therapeutic has been cleared by the agency.
The FDA issued the COVID-19 Enforcement Policy for Digital Health Devices for Treating Psychiatric Disorders Discretion Guidance on April 14, 2020, a move intended to reduce patient and healthcare exposure to the coronavirus. The guidance allows use of digital products designed to treat psychiatric symptoms and disorders. Due to the urgency caused by the pandemic, the FDA implemented the guidance without a public comment period. The guidance remains in effect until the pandemic-related public health emergency ends.
Akili announced that under this new FDA guidance, the company’s ENDEAVOR video game is available for children ages 8 to 12 years old who are diagnosed with attention deficit hyperactivity disorder (ADHD). Akili designed ENDEAVOR to improve attention in children with pediatric ADHD. Akili quoted Scott Kollins, Ph.D., professor of psychiatry, director of the ADHD Program at Duke University School of Medicine, on the toll the pandemic takes on children with ADHD:
“The current environment is hard for any child. Increased stress and upended schedules and routines have a direct impact on our cognition, increasing our distractibility and making it harder to stay focused and to be organized. For children with attention issues associated with ADHD, their daily challenges are exacerbated and many of their support systems are no longer accessible.”
ENDEAVOR is an immersive action video game designed to improve cognitive function and attentiveness through fun, deep engagement, and rewards. According to Akili, three comprehensive studies showed improved attention through digital game-playing, including the STARS-Adjunct study.
Akili is seeking FDA clearance for ENDEAVOR as a prescription treatment for ADHD. Under the recent guidance, ENDEAVOR is available without a prescription and at no cost for three months for qualified families with children diagnosed with ADHD. The current ENDEAVOR release runs on iOS devices.