EndeavorOTC
EndeavorOTC is the first FDA-authorized digital therapeutic treatment for adult ADHD available without a prescription.
What is EndeavorOTC?
EndeavorOTC is an over-the-counter digital therapeutic authorized by the Food and Drug Administration (FDA) for the treatment of adults 18 and older with primarily inattentive or combined-type ADHD. In the U.S., it is indicated to improve attention and functioning as measured by computer-based testing. It is available without a prescription.
EndeavorOTC is not intended to be used as a stand-alone therapeutic and is not a substitution for ADHD medication.
Developed by Akili Interactive, EndeavorOTC is the first FDA-authorized over-the-counter digital therapeutic treatment for adult ADHD. It uses the same proprietary technology as EndeavorRx, an FDA-approved digital therapeutic for the treatment of children ages 8 to 12 with primarily inattentive or combined-type ADHD.
EndeavorOTC is available in the U.S. in the Apple App Store for iOS and the Google Play Store for Android mobile devices.
How Does EndeavorOTC Work?
Through its immersive video game experience, EndeavorOTC presents specific sensory stimuli and simultaneous motor challenges designed to alter pathways in the brain related to focus.
Adults typically interact with EndeavorOTC on mobile devices for 25 minutes daily, five days a week.
The EndeavorOTC games, which challenge players to simultaneously target and navigate through a series of obstacles, are designed to boost cognitive functions related to attention, focus, multitasking, and prioritization.
How Long Does EndeavorOTC Take to Work?
The clinical study supporting EndeavorOTC’s FDA clearance found that, after six weeks of EndeavorOTC use, 83% of participants saw clinical improvements in their ability to focus as measured by the TOVA attentional control score. Nearly three-quarters (72.5%) of participants reported some quality-of-life improvements as measured by the Adult ADHD Quality of Life Scale (AAQoL), and roughly half (45.8%) of adults met a prespecified threshold for clinically meaningful improvement.1
What are the Side Effects of EndeavorOTC?
The clinical trial for EndeavorOTC reported no lasting or serious side effects. Of the 221 adults who received EndeavorOTC for six weeks in the trial, 11 (5%) reported a treatment-emergent adverse device event, most commonly nausea (1.8%) and headache (1.4%).1
What Precautions are Associated with EndeavorOTC?
EndeavorRx may not be appropriate for patients with photosensitive epilepsy, color blindness, or physical limitations that stop a patient from comfortably holding a device.
To learn more about EndeavorOTC, visit EndeavorOTC.com.
What is EndeavorRX?
EndeavorRx, a version of EndeavorOTC designed for children ages 8 to 12 with ADHD, was approved by the FDA in June 2020. Through its immersive video game experience, EndeavorRx presents specific sensory stimuli and simultaneous motor challenges designed to target neural systems in the brain related to attentional control. Children interact with EndeavorRx on mobile devices and typically play for 25 minutes per day, five days a week. It is available by prescription from a licensed healthcare provider.
Learn more about EndeavorRx at www.endeavorrx.com/
Source
1 Stamatis, C.A., Mercaldi, C., Kollins, S.H. (2023). A Single-Arm Pivotal Trial to Assess the Efficacy of Akl-T01, a Novel Digital Intervention for Attention, in Adults Diagnosed With ADHD. Journal of the American Academy of Child & Adolescent Psychiatry. https://doi.org/10.1016/j.jaac.2023.09.510
