By: Mark Stendahl
Boston-based Akili Interactive Labs has gotten one step closer to winning the first FDA approval for a “digital therapeutic,” saying Monday that a video game it developed to treat ADHD had performed well in a pivotal trial.
Akili, a spinout of PureTech Health, announced positive results from the study, in which 348 children and adolescents diagnosed with ADHD played either the company’s tablet-based game or a similar “placebo” game over the course of four weeks. Akili said that patients who used its game, called Project EVO, saw a significant improvement on a measure of sustained attention and inhibitory control, compared to those in the placebo arm.
The privately-held company said it now plans to seek FDA approval in 2018. The game would be the first so-called digital therapeutic approved by the FDA to directly treat a disorder.
In a statement, Scott Kollins, a Duke University School of Medicine professor who led the study, called it “the largest and most rigorous evaluation of a digital medicine” ever performed....