FAQ

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General

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

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.

Has the EndeavorRx treatment been studied in clinical trials?

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.

What are the results of clinical trials with EndeavorRx?

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.

How should the EndeavorRx treatment be used?

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.

Can an adult with ADHD be prescribed EndeavorRx?

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.

Why do I have to obtain EndeavorRx through a prescription?

As an FDA-cleared 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. Examples include primary care physicians and psychiatrists.

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

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.

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

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 (“Screen Time and Children,” No. 54, American Academy of Child & Adolescent Psychiatry, February 2020).

Daily treatments with EndeavorRx last approximately 25 minutes without interruption. This is the approximate time it takes your child to finish the daily treatment’s six to eight missions depending on their play.

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.

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

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.

Will my child enjoy playing EndeavorRx?

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.

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

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.

How much does the EndeavorRx treatment cost?

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. You might be able to use your HSA, FSA, or HRA card to purchase EndeavorRx, and a Patient Assistance Program is available for those that qualify for free access to treatment.

A payment plan is not available at this time.

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

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.

If you have more than one child prescribed EndeavorRx, your children can still use the same device to play EndeavorRx. However, they will not be able to play at the same time. They will also have to – with your help – access their personalized treatment after logging into the respective Akili Account.

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

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 healthcare professional website to learn more. A free EndeavorRx demo can be downloaded from the App Store® and on Google Play™. 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.

How does my child’s healthcare professional prescribe EndeavorRx?

If you’re interested in EndeavorRx for your child, you can make a virtual appointment or talk to your current healthcare professional. If EndeavorRx is right for your child, the healthcare professional will then submit the prescription to Phil Pharmacy. Once the prescription is submitted, you’ll receive a text message from Phil pharmacy with a confirmation link to start your order. You can also contact Phil pharmacy for more coverage and pricing details at 855-977-0975 or visit phil.us/contact.

After payment is made, you’ll receive a pharmacy-issued activation code via text and email to get started.

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

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 App Store® or on Google Play™ (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.

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

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.

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

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 or cancel your upcoming refill(s).

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

How It Works

How does EndeavorRx work?

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.

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

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.

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

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!

Technical

Is an internet connection required to play?

Internet or network connectivity is not required to use the EndeavorRx treatment, but it is required to download, register, activate, and start treatment. Once your child begins treatment, he or she can use the EndeavorRx treatment online or offline. We recommend your child play the EndeavorRx treatment while connected to WiFi so that the app can stay in sync with important updates.

What devices are compatible with EndeavorRx?

iOS Device Minimum Specifications are:

  • iOS version 13.0
  • iPadOS version: 13.1
  • Storage 16 GB
  • Memory 2 GB
  • Network Infrastructure: WiFi
  • Example Devices: iPad Mini 4, iPhone 7, and later models

Android Device Minimum Specifications are:

  • Android OS version: 9.0
  • Storage: 64 GB
  • Memory 4 GB
  • Network Infrastructure: WiFi
  • Example Devices: Samsung Galaxy S8™ or similar, and later models

For more information about device minimum requirements, see our Instructions for Use here or visit the EndeavorRx on the App Store® or on Google Play™.

Is EndeavorRx available outside of the U.S.?

In order to download and activate EndeavorRx, it must be prescribed by a United States licensed physician, and you must be able to access the United States instance of the App Store.

I obtained my child’s code while we were in the U.S., but I recently moved outside the country. Can I still activate my code?

You will be able to activate your code if you are able to access the United States instance of the App Store® or on Google Play™.

Can my child pause during sessions?

Yes, each daily treatment can be paused at any time by tapping the upper-left corner of the screen. Note that there are built-in rest periods between sessions (every four or five minutes on average).

EndeavorRx will display reminders if treatment days are missed, as well as notification when the treatment is soon to expire.

If I have problems activating my code, what should I do?

You can reach out with any technical difficulties by calling 855.977.0975 (Press 3) or visit www.phil.us/contact.

Do I need to sit with my child while they use the EndeavorRx treatment?

That is a decision entirely up to you, but it is not necessary. However, we do recommend that you designate a suitable place free from distractions for your child to play, as well as a time of day. It is fine to experiment with the best time to engage with the EndeavorRx treatment. It is recommended not to play right before bedtime to avoid risk of potential reduction in sleep quality.

Consider these tips to help support you and your child through the EndeavorRx experience.

Support

If I have questions about the EndeavorRx treatment, who do I contact?

If you have any healthcare related questions, you should contact your child’s healthcare professional.

For other questions, if you would like to speak by phone you can call 855.977.0975 (Press 3) or visit www.phil.us/contact.

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

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

EndeavorRx:

Indications, Safety and Cautions

Indications:
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.

Safety:
Of 538 participants using EndeavorRx, 50 participants (9.3%) experienced treatment-related adverse events (probable, likely), and three participants experienced treatment-related adverse events with the digital control, in studies where a control was used. EndeavorRx associated adverse events included frustration (6.1%), headache (1.3%), dizziness (0.6%), emotional reaction (0.4%), nausea (0.4%), and aggression (0.2%). There were no serious adverse events. All adverse events were generally transient. Only 3 events led to device discontinuation, and no subject reported lasting or irreversible effects after discontinuation.

Cautions:
Rx only: Federal law restricts this device to sale by or on the order of a physician. EndeavorRx should only be used by the patient for whom the prescription was written. For medical questions, please contact your child’s healthcare provider. If you are experiencing a medical emergency, please dial 911. EndeavorRx is not intended to be used as a stand-alone therapeutic and is not a substitution for your child’s medication.

If your child experiences frustration, emotional reaction, dizziness, nausea, headache, eye-strain, or joint pain while playing EndeavorRx pause the treatment. If the problem persists contact your child’s healthcare provider. If your child experiences a seizure stop the treatment and contact your child’s healthcare provider.

EndeavorRx 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.

Please follow all of your mobile device manufacturer’s instructions for the safe operation of your mobile device. For example, this may include appropriate volume settings, proper battery charging, not operating the device if damaged, and proper device disposal. Contact your mobile device manufacturer for any questions or concerns that pertain to your device.