First-Ever Therapeutic Video Game for Adult ADHD Approved By FDA

The FDA has approved EndeavorOTC to treat attention-deficit/hyperactivity disorder (ADHD) in adults, Akili announced yesterday in a press release. This is the first and only FDA-approved over-the-counter digital treatment for adult ADHD.

It is available for download in the United States on the Apple App Store and Google Play Store.

EndeavorRx, a version of EndeavorOTC designed for children with ADHD, was approved by the FDA in June 2020. Approval was granted after researchers noted that 68% of children in the trial experienced a clinically meaningful change after two months of playing. The full trial was published in The Lancet Digital Health journal. EndeavorRx is recommended to be used 25 minutes a day for five days a week over at least four weeks.

Adult ADHD is characterized by lower-than-normal functioning in the executive system of the brain, which acts as the command center for the rest of the brain. ADHD can be categorized into two sets of symptoms – inattentiveness or hyperactivity. Adults with inattentive ADHD may have poor organizational skills, lack attention to detail and find themselves easily distracted. It used to be referred to as ADD (attention deficit disorder).

Adults with hyperactive ADHD may fidget frequently, lack self-restraint and have difficulties with social boundaries. Men are more likely to receive an ADHD diagnosis because they often present with hyperactivity. Women are more likely to have inattentive ADHD, which leads to a delay in diagnosis or a misdiagnosis.

The clinical study for EndeavorOTC, called STARS-ADHD-Adult, involved 221 adults who received EndeavorOTC for six weeks. Success rates were determined using various ADHD diagnostic tests. Most (83%) participants reported improvement measured using the TOVA (Test of Variables of Attention) attention control score. In addition, almost three-quarters (72%) reported improved quality of life using the Adult ADHD Quality of Life Scale (AAQoL). Overall, about half (45.8%) of participants met a clinical threshold for meaningful improvement.

There were only minor adverse effects with 1.8% of participants reporting nausea and 1.4% noting a headache after treatment.

“EndeavorOTC is not intended to be a replacement for any form of treatment and should be used as part of a therapeutic program that may include clinician-directed therapy, medication, and/or educational programs, which further address symptoms of the disorder,” the press release reads. “It is recommended that patients seek care from a medical health care provider in conjunction with its use.”

This latest development for Akili follows their announcement last year in which they said they were shifting towards a focus on non-prescription digital therapies. They stated that a consumer model will reduce reliance on payers and grow their business. Last January, they laid off 30% of their workforce.