EndeavorOTC®

Overview

Medical condition:

Attention-Deficit/Hyperactivity Disorder (predominantly inattentive and combined presentations)

Target patient population:

Adults 18 years of age and older with primarily inattentive or combined-type ADHD

What to expect:

EndeavorOTC is a digital, non-drug treatment delivered through an action video game on a mobile device that improves attention and day-to-day functioning in adults with ADHD.

Note: for more information, please visit https://www.endeavorotc.com/.

Clinical Overview

Indications for use:

EndeavorOTC is a digital therapeutic indicated to improve attention function, ADHD symptoms, and quality of life in adults 18 years of age and older with primarily inattentive or combined-type ADHD.

Outcomes:

In a recent clinical trial, EndeavorOTC significantly improved focus, attention, and overall quality of life in adults struggling with ADHD symptoms. After 6-weeks of EndeavorOTC use, 83% of participants saw clinical improvements in their ability to focus after 6 weeks, 73% reported better quality of life improvements, 37% no longer exhibited an attention deficit, 33% had clinically meaningful improvements in ADHD symptoms, and 61% reported clinically meaningful improvements in productivity.

Directions:

Daily treatments of EndeavorOTC last approximately 25 minutes. For best results, EndeavorOTC should be used 5 days a week, for at least a 6-week period. Clinical trial results showed that the best results come with this routine, although many participants showed substantial improvements in attention and clinical functioning with less usage.

Risks & warnings:

EndeavorOTC may not be appropriate for patients with photo-sensitive epilepsy, color blindness, or physical limitations that restrict use of a mobile device.

Place in therapy:

Complementary to current therapy; not a substitute for medication.

Product Access

Product description:

EndeavorOTC is a digital, game-based therapeutic that can be accessed on a mobile device and improves attention and day-to-day functioning in adults with ADHD.

Prescription status:

No, a prescription is not required.

Patient access:

EndeavorOTC is available over-the-counter. Patients can download EndeavorOTC directly from the Apple or Google Play Store. Both monthly and annual subscriptions are available.

Use of this product requires access to:

• Internet or wifi
• a mobile phone or tablet

Coverage options:

Costs for EndeavorOTC can be submitted for coverage obtained via FSA or HSA. Please check with your FSA or HSA provider on how to submit these costs.

Product availability:

EndeavorOTC is currently only available in the USA.

EndeavorOTC is being made available under the FDA’s Enforcement Policy for Digital Health Devices For Treating Psychiatric Disorders During the Coronavirus Disease 2019 (COVID-19) Public Health Emergency, and has not yet been cleared/authorized by the FDA (it is under review now).

Clinical Trials

The provided set of evidence represents a sample of conducted studies. For a comprehensive collection contact manufacturers directly.

• Study Title: A single arm pivotal trial to assess the efficacy of AKL-T01, a novel digital intervention designed to improve attention, in adults diagnosed with ADHD – 
  Study Design: Multicenter, single-arm
  Outcomes: After 6-weeks of AKL-T01 use, adults had a significant improvement in objective attention (as measured by the TOVA-ACS, or Test of Variables of Attention Attention Composite Score), ADHD symptom severity (ADHD-RS, ADHD-Rating Scale), and quality of life (AAQOL, Adult ADHD Quality of Life). There were no serious adverse events reported, with 5% of participants experiencing any type of adverse event (the most common being nausea [1.8%] and decreased frustration tolerance [0.9%]).

Note: for more research, please visit https://www.akiliinteractive.com/publications.