Akili Interactive Labs doesn’t develop medicines or molecules, but it’s still hoping to earn a prescription. The company recently reported that its video game for kids living with ADHD met its primary end point in a late-stage clinical trial.
The game is designed to have therapeutic benefit, not just an educational nudge like other healthcare apps. It targets key neurological pathways that control attention and impulsivity. In the study, nearly 400 children between the ages of 8 and 12 played the game on a tablet for four weeks.
The results: statistically significant improvements on attention and inhibitory control, compared to children who were given a different action-driven video game that acted as a placebo.
Akili is expected to file for approval with the Food and Drug Administration in early 2018. The game acts as a medical device and comes with specific dosage recommendations, including a starter pack of 30-minute sessions, given five days each week for four weeks. Clinical study is also under consideration for versions of the game that might help adult depression, pediatric autism and multiple sclerosis.
Why this matters
- Although this is a new category for the FDA, a recent approval of an app for treating substance abuse suggests the agency is thinking broadly about therapeutic impact – regardless of delivery method.
- In this case, the FDA may be ahead of doctors and insurers. Many questions remain about how a product like this game would be integrated into clinical practice and reimbursed by payers.
- Commercialization strategies will increasingly include more than just a pill – from companion diagnostics to interactive education tools to true non-pharmaceutical interventions like this one. Understanding how to navigate the review and reimbursement process will be critical to future success.