EndeavorRx®

Overview

Medical condition:

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

Target patient population:

Children ages 8-17 years old with primarily inattentive or combined-type ADHD who have demonstrated attention issues.

What to expect:

EndeavorRx is a digital prescription treatment that is delivered through an action video game. The treatment programmed into the game was designed to challenge a child’s attentional control during gameplay, requiring focus and flexibility to manage multiple tasks at the same time.

EndeavorRx is not intended as a stand-alone therapeutic, nor is it a substitute for your child’s medication.

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

Clinical Overview

Indications for use:

EndeavorRx is a digital treatment indicated to improve attention function as measured by computer-based testing in children ages 8-17 years old with primarily inattentive or combined-type ADHD who have demonstrated attention issues and should be considered for use as part of a therapeutic program. Refer to this link for a complete Indication for use.

Outcomes:

Patients who engaged with EndeavorRx demonstrated improvements in a digitally assessed measure of sustained and selective attention (measured by TOVA®).

EndeavorRx demonstrated improvements in ADHD impairment (measured by IRS), with responder rates ranging 48*-50%** after 1-month treatment and 68%** following a second month of treatment.

*In STARS-ADHD: Kollins et al, 2020
** This is STARS-ADJUNCT : Kollins et al, 2021

IRS= Impairment Rating Scale. (Fabiano et al, 2006)

Directions:

One prescription will enable a patient to receive 3 months of access to EndeavorRx treatment.

Daily treatments with EndeavorRx last approximately 25 minutes and it is recommended that they are completed by the patient without interruption. Therefore, try to ensure that the patient has approximately 25 minutes of uninterrupted time to complete each daily treatment. Try to fit EndeavorRx into your family’s routine and make it a habit. You can make use of reminders in the game or any other tools you use for managing your family’s schedule.

Risks & warnings:

There were no serious adverse events. Of 538 participants using EndeavorRx, 50 participants (9.3% of subjects) experienced side effects, including frustration, headache, dizziness, emotional reaction, nausea, or aggression.

The EndeavorRx app may not be appropriate for patients with photo-sensitive epilepsy, color blindness, or physical limitations that restrict use of a mobile device; parents should consult with their child’s healthcare provider. EndeavorRx is only available through a prescription and is not intended as a stand-alone therapeutic or a substitute for medication.

Place in therapy:

Prescribed by a healthcare professional and used alongside a current treatment plan. EndeavorRx should be considered for use as part of a therapeutic program that may include clinician-directed therapy, medication, and/or educational programs, which further address symptoms of ADHD. EndeavorRx is not intended to be used as a stand-alone therapeutic and is not a substitute for your child’s ADHD medication.

Product Access

Product description:

EndeavorRx is the first-and-only FDA-authorized prescription treatment for inattention in children with ADHD delivered through a video game experience.

Prescription status:

A prescription from a qualified healthcare provider is required.

Patient access:

An enrollment activation code is generated for patients after their healthcare provider sends a prescription to a specialty pharmacy. Upon completion of registration and payment with the pharmacy, patients’ parents or legal guardians will download EndeavorRx in the App Store® or on Google Play™ and apply the activation code to begin treatment.

One prescription and payment will enable a patient to receive approximately 3 months of access to EndeavorRx treatment.

Use of this product requires access to:

• Internet or wifi
• iPhone® or iPad® running iOS 13.0 or later or on – Devices supporting Android™ 9.0 or newer

Provider access:

Prescriptions can be sent to Phil pharmacy through EHR found as PhilRx (Columbus, OH). For more information please visit this site.

Coverage options:

EndeavorRx may be covered by health insurance and Akili is actively working to improve options. If a patient’s health insurance doesn’t cover EndeavorRx, a discount will be automatically applied. A Patient Assistance Program is available for those that qualify for free access to treatment.

Product availability:

EndeavorRx is available in:

• USA: FDA-authorized Class II Medical Device

Clinical Trials

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

• Study Title: Effectiveness of a digital therapeutic as adjunct to treatment with medication in pediatric ADHD – 2021
  Study Design: Multicenter, open-label effectiveness study
  Outcomes: The change from baseline to day 28 in the impairment rating scale (IRS) overall severity score was significantly improved for participants in both the On Stimulants cohort ( -0.7, p<0.001) and No Stimulants cohort ( -0.5, p<0.001).
  The change from baseline to day 28 in ADHD-RS Total was significantly improved for participants in the On Stimulants cohort ( -6.1, p<0.001) and No Stimulants cohort ( -7.4, p<0.001). The mean clinical global impression scale – improvement (CGI-I) score at day 28 was 3.3 in the On Stimulants cohort and 3.4 in the No Stimulants cohort for the ITT population (both p-values <0.001).
  The symptoms/impairments as measured with IRS, ADHD-RS and CGI-I remained significantly improved from baseline at day 56 (after 1 month treatment pause) and day 84 (after 2nd treatment month). ll p-values <0.001 relative to baseline.
• Study Title: A novel digital intervention for actively reducing severity of paediatric ADHD (STARS-ADHD): a randomised controlled trial – 2020
  Study Design: Randomized Controlled Trial
  Outcomes: EndeavorRx showed a statistically significant improvement in TOVAⓇ API compared to digital control (0.93 vs 0.03; p=0.006). There were no intervention group differences for secondary measures. The within-group improvements were all significant (p<0.001). Compared to control, mean changes in ADHD-RS Total, ADHD-RS Inattentive, and IRS numerically favored EndeavorRx.

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