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.

Read more on STAT News

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.

About the Author:

As Managing Director of Innovation for Syneos Health Communications, Leigh is responsible for shaping the company’s perspective on the next era of healthcare marketing. Through thought leadership, strategic innovation workshops and new products and capabilities, Leigh focuses on identifying marketing approaches that will fuel that new era and generate significant growth for clients. Leigh has worked with Fortune 1000 companies to craft their digital, mobile, social and CRM strategies for over 17 years. She’s worked for category-leading agencies in retail, public affairs, B2B technology, and higher education. Prior to moving to Syneos Health Communications, she had several leadership roles at one of our agencies, GSW. There, she founded an innovation practice fueled by the zeitgeist and spearheaded digital and innovation thinking across the business. Leigh has taken a special interest in complex healthcare products that can change lives in meaningful ways. She was recently a strategic lead on the 3rd largest launch in pharmaceutical history: Tecfidera. Before that she had keys roles with Eli Lilly Oncology, Abbott Nutrition, Amgen Cardiovascular, and Eli Lilly Diabetes. A critical part of Leigh’s work is trends and new ideas. Every year, she convenes a group of trend watchers from across our global network to identify the shifts most critical to healthcare marketers. Leigh is a sought-after writer and speaker. Recognized as one of the most inspiring people in the pharmaceutical industry by PharmaVoice, Leigh also was recognized as a Rising Star by the Healthcare Businesswomen's Association (HBA) for her overt passion, industry thought leadership and significant contributions in new business, strategy and mentoring.