DTx Product Profile

EndeavorRx®

Product Highlight

Condition targeted:

ADHD

How it works:

EndeavorRx is a digital therapeutic indicated to improve attention function as measured by computer-based testing in children ages 8-12 years old with primarily inattentive or combined-type ADHD, who have a demonstrated attention issue.

Impact:

Patients who engaged with EndeavorRx demonstrated improvements in a digitally assessed measure of sustained and selective attention.

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

 

Overview

Medical condition:

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

Target patient population:

Children ages 8-12 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.

Clinical Overview

Indications for use:

EndeavorRx is a digital treatment indicated to improve attention function as measured by computer-based testing in children ages 8-12 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:

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:

The game-changing
ADHD treatment.

EndeavorRx is a first-of-its-kind ADHD treatment for kids 8-12, delivered through an immersive video game experience. Created by a team of world-class neuroscientists and award-winning game designers, it uses sensory stimuli + simultaneous motor challenges designed to target areas of the brain that play a key role in attention function.

Clinical Trials

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