FDA Clears Over-the-Counter Video Game-Based ADHD Therapy for Adults

The Food and Drug Administration (FDA) has cleared EndeavorOTC^Ⓡ, an over-the-counter (OTC) treatment for adults with attention-deficit/hyperactivity disorder (ADHD).

EndeavorOTC is a digital therapeutic that uses sensory and motor stimuli to target and activate the prefrontal cortex of the brain through an action video game experience. The device can be used as part of a therapeutic program that may include clinician-directed therapy, medication, and/or educational programs.

The FDA clearance was based on data from a clinical study (ClinicalTrials.gov Identifier: NCT05183919) that included 221 adults diagnosed with ADHD. Study participants received EndeavorOTC for 6 weeks. The primary endpoint was the change in test of variables of attention (TOVA^®) attention comparison score (ACS) after 6 weeks.

Findings showed 83% of participants had an improvement in focus (as measured by TOVA-ACS score). Additionally, 72.5% of participants reported quality of life improvement (as measured by the Adult ADHD Quality of Life scale) and 45.8% met a prespecified threshold for clinically meaningful improvement.

Significant improvements in ADHD symptoms were also observed based on the change in  Attention Deficit Hyperactive Disorder Rating Scale-5 inattention subscale and total scale scores (P <.0001 for both). Treatment-emergent adverse device events were reported in 11 participants. These included nausea (1.8%) and headache (1.4%). 

EndeavorOTC is currently available in the Apple App Store and Google Play Store. A prescription-only version, EndeavorRx, was previously cleared for pediatric and adolescent patients with primarily inattentive or combined-type ADHD.

This article originally appeared on MPR