Growing up, my brother and I frequently played video games. I believe we owned every console released during the 1990s. My dad even wrote his own video game in the 1980s, playable on a floppy disk drive of a computer. While I have probably argued at some point in favor of the therapeutic value of video games, I never imagined that a medical agency would adopt that logic. However, on June 15, 2020, the U.S. Food and Drug Administration (FDA) issued a peculiar decision. For the first time ever, the FDA approved a video game as a prescription-only therapeutic. The video game, EndeavorRx, treats attention deficit hyperactivity disorder (ADHD) in patients from 8 to 12 years of age. With this decision, the FDA opened up the possibility of widespread prescription video game therapeutics.

A company must overcome several daunting hurdles before obtaining FDA approval of a prescription treatment. Test results must be obtained and verified, which typically takes several years. Many therapeutics fail to receive full FDA approval, making success within the pharmaceutical industry difficult to predict. With a challenging path ahead, developer Akili Interactive Labs pushed forward obtaining the required data related to EndeavorRx in 2016.

Passing the FDA Approval Hurdle

Citing to a current lack of access to ADHD treatment barriers, Akili’s study focused on digital-based therapeutics. More than 600 children participated in the double-blind study. The test therapeutic, EndeavorRx, utilized focus-based mechanics to measure responses to instructed stimuli. Specifically, a child playing EndeavorRx navigates a vehicle on a screen to gather resources while avoiding obstacles. The control therapeutic included word-building mechanisms that are not associated with ADHD. Results of the study showed a dramatic improvement for the test group as compared to the control group. The study notes that the video game therapeutic is not a replacement for current treatments, but rather a component of a treatment plan.

Change in Test of Variables of Attention (TOVA) between test group and control group. Kollins, Scott H, et al. “A Novel Digital Intervention for Actively Reducing Severity of Paediatric ADHD (STARS-ADHD): a Randomised Controlled Trial.” The Lancet Digital Health, vol. 2, no. 4, 2020, pp. e168–e178., doi:10.1016/s2589-7500(20)30017-0.

Based on the test data, the FDA granted marketing authorization for EndeavorRx as a prescription video game therapeutic. In addition, the FDA created a new process through which similar video games can receive approval. Soon, we could see an explosion in treatment plans including prescription video game therapeutics.

Akili recently scored another boost to their tech portfolio, receiving patent protection for their video game. While the software-based patent could face scrutiny moving forward in an ever-changing patent landscape, Akili’s portfolio is stronger having FDA approval and patent protection.