Name: EndeavorRx™
Address: 5th Floor, 125 Broad Street, Boston, Massachusetts, MA 02110, USA
Telephone: 855.977.0975

Question 1

What is the EndeavorRx® treatment and what is it used for?

Accepted Answer

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. Patients who engage with EndeavorRx demonstrate improvements in a digitally assessed measure, Test of Variables of Attention (TOVA®), of sustained and selective attention and may not display benefits in typical behavioral symptoms, such as hyperactivity. 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 the disorder. EndeavorRx is only available through a prescription, and is not a substitute for your child’s ADHD medication. You should consult with your child’s healthcare professional and review the Instructions for Use before using the EndeavorRx treatment. You can find the Instructions for Use here.

Question 2

Has the EndeavorRx treatment been studied in clinical trials?

Accepted Answer

EndeavorRx has been evaluated in over 600 children with ADHD across 5 clinical studies. EndeavorRx has been shown 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.

Question 3

What are the results of clinical trials with EndeavorRx?

Accepted Answer

The EndeavorRx treatment has been evaluated in over 600 children with ADHD across 5 clinical studies: A study of 348 children with ADHD (not receiving ADHD medication), where EndeavorRx was used for a 4-week treatment period, showed improvements in attention function (as measured by computer-based testing) and attention-related ADHD symptoms and impairments. A study of 206 children with ADHD (on stimulant medication or not receiving any ADHD medication), where EndeavorRx was used for a 4-week period, followed by a treatment pause of one month and a subsequent second 4-week treatment period. Improvements in attention-related ADHD symptoms and impairments were similar in magnitude to those seen in other studies and further improved with the second treatment period in children on or off ADHD medication. Three separate studies of 40, 20 and 19 children with ADHD, where the EndeavorRx treatment was used for a 4-week treatment period and showed improvements in attention measures and attention-related ADHD symptoms.

Question 4

How should the EndeavorRx treatment be used?

Accepted Answer

EndeavorRx is available in 3-month prescriptions. It is recommended EndeavorRx should be used for approximately 25 minutes per day, 5 days per week, for 4 weeks, or as recommended by your child’s healthcare professional. Unlike an action video game, there is no way to “win” EndeavorRx. The algorithm continues to challenge the child at a specific and consistent level of difficulty throughout the game. In addition, the multitasking rules get more complex as the game progresses through the four worlds. As long as the child is playing consistently and trying his/her best, the child is engaging with the treatment as intended. If your child experiences any side effects from using the EndeavorRx treatment, or if you have any questions about the benefits of EndeavorRx treatment, please contact your child’s healthcare professional to discuss your child’s experience.

Question 5

Why do I have to obtain EndeavorRx through a prescription?

Accepted Answer

As an FDA-approved medical device, EndeavorRx is designed for the treatment of a medical disorder and should be used under the supervision of a medical professional who can manage a broader treatment program and can oversee adherence and compliance with the treatment program.

Question 6

My child does not have ADHD, but I think the EndeavorRx treatment might be right for him/her. Can you advise?

Accepted Answer

The EndeavorRx treatment is indicated for children ages 8-12 years old with primarily inattentive or combined-type ADHD who have a demonstrated attention issue. If you have any questions about the suitability of this for your child, please discuss with your child’s healthcare professional. To help start the conversation, download, review, and take the discussion guide to your next appointment.

Question 7

The EndeavorRx treatment is delivered via a digital screen. Should I be fearful of screen time risks?

Accepted Answer

We understand that screen time can be of concern to parents and physicians. We are aligned with the American Academy of Pediatrics in its policy on media use in school-age children and adolescents and the recommendation to set consistent limits on hours per day on media. The EndeavorRx treatment is limited to approximately 25 minutes of screen exposure per treatment day. This is the time it takes your child to finish the daily treatment’s five missions. The EndeavorRx treatment will automatically lock after each daily treatment session is completed. Be sure to let your child know that it is OK to occasionally take a break from treatment for a few minutes in order to avoid excess eye strain or fatigue.

Question 8

Will my child experience any side effects from using the EndeavorRx treatment?

Accepted Answer

There were no serious adverse events seen in any clinical trials of EndeavorRx. Of 538 participants using EndeavorRx in clinical trials, 50 participants (9.3%) experienced treatment-related adverse events, including frustration (6.1%), headache (1.3%), dizziness (0.6%), emotional reaction (0.4%), nausea (0.4%), and aggression (0.2%). If your child experiences frustration, emotional reaction, dizziness, nausea, headache, eyestrain, or joint pain while playing EndeavorRx, pause the treatment. If the problem persists, contact your child’s healthcare professional. If your child experiences a seizure, stop the treatment and contact your child’s healthcare professional. The EndeavorRx treatment is delivered through a video game experience. In order to support EndeavorRx’s engagement and fun components, the gameplay experience sometimes includes flashing lights and altering light patterns. This is common among video games played by children. A very small percentage of individuals who play video games may experience epileptic seizures or blackouts when exposed to certain light patterns or flashing lights. Playing video games may trigger epileptic seizures or blackouts in these individuals. These conditions may also trigger previously undetected epilepsy or seizures in persons who have no prior history of epilepsy or seizures. If your child, or anyone in your family, has an epileptic condition or has had seizures of any kind, please consult your child’s physician before using the EndeavorRx treatment. The EndeavorRx treatment may not be appropriate for children with color blindness or physical limitations that restrict use of a mobile device. If your child has any of these conditions, please consult with your child’s physician before using the EndeavorRx treatment.

Question 9

Will my child enjoy playing EndeavorRx?

Accepted Answer

By design, EndeavorRx can be challenging, repetitive, and even feel discouraging to your child. EndeavorRx is different from other action video games that a child might play. The treatment programmed into the gameplay experience was designed to challenge a child’s attentional control during gameplay, requiring focus and flexibility to manage tasks at the same time.

Question 10

Does my family’s data remain safe and private if my child uses the EndeavorRx treatment?

Accepted Answer

We understand how important it is to protect your family’s privacy. Akili uses industry standard privacy and security measures to protect your child’s health data, in accordance with terms of our Privacy Notice for the EndeavorRx treatment located here.

Question 11

How much does the EndeavorRx treatment cost?

Accepted Answer

EndeavorRx costs less than $100/month for a 3-month prescription. EndeavorRx may be covered by your health insurance and we’re actively working to improve coverage. If your health insurance doesn’t cover EndeavorRx, a discount will be automatically applied to all prescriptions through our online pharmacy partner, reducing the regular price of $450 to less than $300 for a 3-month prescription. A Patient Assistance Program is available for those that qualify for free access to treatment.

Question 12

After I purchase EndeavorRx, can it be used for more than one child?

Accepted Answer

An EndeavorRx activation code can only be used by the individual for whom it was prescribed. If multiple children in your household have been prescribed EndeavorRx, you will receive an individual activation code for each child and individual payment request emails for each activation code. It’s important to remember that the treatment’s technology adapts real-time and between treatment sessions to the individual child’s level, designed to continuously challenge and encourage them to improve their performance.

Question 13

Is there a way for my child’s healthcare professional to test out the treatment before prescribing it for my child?

Accepted Answer

If your child’s healthcare professional is interested in learning more about EndeavorRx prior to prescribing it as a treatment for your child, please direct him/her to our website to learn more. A free EndeavorRx demo can be downloaded from the Apple App Store®. This demo is for look and feel only, and does not contain any therapeutic benefit. This demo should not be used as a substitute for the actual EndeavorRx treatment.

Question 14

Can my child test out the treatment before I make the purchase?

Accepted Answer

There is a brief playable demo for you to experience in order to get the look and feel of EndeavorRx. To access the demo, download the EndeavorRx app in the Apple App Store® (or update the app if you have the previous version on your mobile device). Once you open the app, just click “Play Demo” to get started. Remember: this demo is for look and feel only, and does not contain any therapeutic benefit. This demo should not be used as a substitute for the actual EndeavorRx treatment.

Question 15

I have questions in general about my child using the EndeavorRx treatment. What should I do?

Accepted Answer

You should communicate with your child’s healthcare professional. You can also reach out by calling Phil pharmacy. Call 855.977.0975 (Press 3) or visit www.phil.us/contact. In the meantime, you can also review the EndeavorRx Instructions for Use found here.

Question 16

How do I renew my child’s prescription for EndeavorRx?

Accepted Answer

Subsequent refills will be billed and dispensed by Phil pharmacy. It’s possible that your prescription is set to auto-refill — if so, you should have been contacted by Phil pharmacy, which will provide details regarding how to activate your next cycle. If you have any questions about refilling your prescription, you can contact Phil directly by calling 855.977.0975 (Press 3) or visit www.phil.us/contact

Question 17

How does EndeavorRx work?

Accepted Answer

Evaluated in over 600 children with ADHD across 5 clinical studies¹, the EndeavorRx treatment uses sensory stimuli and simultaneous motor challenges designed to target areas of the brain that play a key role in attention function. ¹STARS-ADHD Pivotal Study: Kollins et al, Lancet Digital Health, 2020. STARS-Adjunctive Study: Data on File, Akili, 2020. (manuscript in progress). Proof of concept study: Davis et al, PLOS One, 2018. Pilot studies: Anguera et al., PLOS One, 2017. Yerys et al., J Autism Dev Disord, 2019G When using EndeavorRx, the goal is for your child to successfully navigate their character through a course while collecting targets and avoiding bumping into obstacles. These actions require focus and flexibility to manage multiple tasks at the same time.

Question 18

Why does my child need to play 5 days per week, 25 minutes per day? Is it possible to play less or more? studied in clinical trials?

Accepted Answer

EndeavorRx is recommended to be used for approximately 25 minutes per day, 5 days per week, over initially at least 4 consecutive weeks, or as recommended by your child’s healthcare professional. Your child’s healthcare professional may follow these recommendations or may make a different treatment decision suitable for your child. Always follow your child’s healthcare professionals treatment recommendations. If your child has experienced any side effects from using the EndeavorRx treatment, or if you have any questions about the benefit of continuing with the EndeavorRx treatment, please contact your child’s healthcare professional to discuss your child’s experience and determine if additional treatment cycles are warranted.

Question 19

My child has “finished” all the levels — can they continue playing?

Accepted Answer

Yes. Even if your child has unlocked all of the worlds in EndeavorRx, treatment may not be complete! They should continue to play EndeavorRx as instructed by your child’s healthcare professional. They can replay their favorite levels again, attempting to beat previous scores, completing new quests, and unlocking more rewards!

Question 20

How can my child’s healthcare professional learn more about EndeavorRx?

Accepted Answer

Your child’s healthcare professional can visit hcpendeavorrx.com to learn more about EndeavorRx.

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