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Link: https://www.endeavorrx.com/

Organization: Akili Interactive Labs, Inc.

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1623772151

EndeavorRx®: The first-and-only FDA-cleared treatment delivered through a video game experience
EndeavorRx is available in 3-month treatment periods, during which your child will use the treatment as prescribed by a healthcare professional.

The EndeavorRx app 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 a demonstrated attention issue and should be considered for use as part of a therapeutic program.

EndeavorRx is an FDA-cleared medical device and must be prescribed by a healthcare professional. It is not intended as a stand-alone therapeutic, nor is it a substitute for your child's medication.

Watch: EndeavorRx Gameplay Trailer

Getting Started with EndeavorRx

01: Consult

Contact your child's healthcare professional to discuss EndeavorRx. EndeavorRx is a new prescription video game treatment, and your child's healthcare professional may not be familiar with it. To help start the conversation, download, review, and take the discussion guide to your next appointment.

02: Confirm

EndeavorRx is available through our pharmacy partner, Phil. If your child's healthcare professional decides EndeavorRx is appropriate, they can send the prescription to Phil pharmacy.
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.

Contact Phil pharmacy for more coverage and pricing details. Call 855-977-0975 or visit phil.us/contact.

Once the prescription is submitted, look out for a text message from Phil pharmacy with a confirmation link to start your order. Phil can't fill your Rx without this step!

Once enrolled, you'll get a text with a link to confirm payment.

03: Activate

Let the games begin! After payment receipt, you'll receive a pharmacy-issued activation code via text and email. You can download the EndeavorRx app from the Apple App Store and apply the activation code to begin treatment. Be sure to check out Treatment Tips for additional information on getting started.

Interested in a refill? Subsequent refills will be billed and dispensed by Phil pharmacy, on schedule and automatically.
To stay up to date with EndeavorRx, join our email list Please see our Privacy Notice for EndeavorRx for details on how we safeguard, process, and use your information.

Stay up to date with EndeavorRx

Curious about EndeavorRx and wondering if it's right for your child? Just complete this form to get more information & receive our latest updates. Please note that all fields are required in order to submit your form.

Daily Treatment

Experienced through an immersive and challenging digital therapy on an Apple iOS mobile device

Personalized Experience

Proprietary and patented technology adapts real-time and between treatment sessions to your child's level, continuously challenging and encouraging them to improve their performance

Entirely New Option

Prescribed by your child's healthcare professional and used alongside your current treatment plan

At Akili, we understand the impact of inattention on children and families. To help address this problem, our team of world-class neuroscientists and video game designers collaborated to strive to improve attention in a truly unique way.

How does EndeavorRx work?

Evaluated in over 600 children with ADHD across 5 clinical studies ¹, 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.

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.

In a controlled clinical trial, EndeavorRx demonstrated a significant improvement in a computer-based measure of attention (TOVA® API) compared to a digital control word game.

In our randomized, controlled clinical study, EndeavorRx improved objective attention in children with ADHD ages 8-12. In addition, 48% of parents indicated that EndeavorRx improved ADHD-related day-to-day impairment and 56% of parents indicated the treatment improved their child's attention. ²

In an open-label study, 68% of parents reported improvement in ADHD-related impairments after a second month of EndeavorRx. In addition, up to one third of children had a clinically meaningful change in ADHD symptoms after one month of treatment with EndeavorRx; this increased to 45% after a second month of treatment. These effects were similar whether children were on or off ADHD medication. ³

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. 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%).

Watch: How EndeavorRx Works

¹ STARS-ADHD Pivotal Study: Kollins et al, Lancet Digital Health, 2020. Kollins et al, npj digital medicine, 2021. 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, 2019

² STARS-ADHD Pivotal Study: Kollins et al, npj digital medicine 2021.

³ Kollins et al, npj digital medicine, 2021.

What's treatment like?

It's important to know that EndeavorRx might feel repetitive and challenging for some children at times, and it takes commitment from you and your child to see results. Although there are exciting rewards and motivational elements designed into the treatment, you should expect tough moments on the path to improving your child's attention. But, making this part of your family's routine can help. Remember: you and your child can do this, and we're here to help.

Here are some treatment tips to help guide you and your child through the EndeavorRx experience.

How and when should EndeavorRx be considered for use

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.

You should contact your child's healthcare professional and review the important indications, safety and cautions information in the Instructions for Use before using the EndeavorRx treatment.

What patients and caregivers have to say about EndeavorRx...

The views and opinions expressed in these videos are unique to the parents featured and not necessarily representative of Akili's views.

Adam & Ash's Story

Emily & Brittany's Story

Kate, Kara & Trey's Story

Interested in trying a demo of EndeavorRx before obtaining a prescription?

In the 5-minute demo, you can expect your character to navigate through 'Planet Frigidus,' and tap and steer in order to progress and earn rewards. This demo should provide you with a better understanding of the EndeavorRx gameplay mechanics and overall experience. The demo is for look and feel only, and does not contain any therapeutic benefit. It should not be used as a substitute for the actual EndeavorRx treatment.

Use this guide to start a conversation with your child's healthcare professional about EndeavorRx

Tracking and monitoring your child's ADHD is now at your fingertips.

Designed with you and your child at the forefront, we created the ADHD Insight™ app to empower you to better understand your child's ADHD. In just a few minutes a day, you can keep track of the ups and downs and celebrate the little wins.

Getting Started with EndeavorRx

01: Consult

Contact your child's healthcare professional to discuss EndeavorRx. EndeavorRx is a new prescription video game treatment, and your child's healthcare professional may not be familiar with it. To help start the conversation, download, review, and take the discussion guide to your next appointment.

02: Confirm

EndeavorRx is available through our pharmacy partner, Phil. If your child's healthcare professional decides EndeavorRx is appropriate, they can send the prescription to Phil pharmacy.
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.

Contact Phil pharmacy for more coverage and pricing details. Call 855-977-0975 or visit phil.us/contact.

Once the prescription is submitted, look out for a text message from Phil pharmacy with a confirmation link to start your order. Phil can't fill your Rx without this step!

Once enrolled, you'll get a text with a link to confirm payment.

03: Activate

Let the games begin! After payment receipt, you'll receive a pharmacy-issued activation code via text and email. You can download the EndeavorRx app from the Apple App Store and apply the activation code to begin treatment. Be sure to check out Treatment Tips for additional information on getting started.

Interested in a refill? Subsequent refills will be billed and dispensed by Phil pharmacy, on schedule and automatically.
To stay up to date with EndeavorRx, join our email list Please see our Privacy Notice for EndeavorRx for details on how we safeguard, process, and use your information.

EndeavorRx: Indications, Safety and Cautions

Indications for Use:
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.

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.

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.

BY

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EndeavorRx® - FDA-approved Video Game Treatment for ADHD.

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1623772151 EndeavorRx®: The first-and-only FDA-cleared treatment delivered through a video game experience EndeavorRx is available in 3-month treatment periods, during which your child will use the treatment as prescribed by a healthcare professional.

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Year: January 12, 2024

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Attention-deficit hyperactivity disorder (ADHD) is a common disorder. Symptoms include trouble staying focused, paying attention, and elevated activity levels (Oh et al., 2024).

Treatments may include medical and non-medical interventions, which have illustrated short-term results. Medications may be ineffective for some patients because of parent’s concerns about side effects and diversion (Oh et al., 2024).

EndeavorRx is a prescription-only game-based digital therapeutics for pediatric patients primarily lacking concentration or compound ADHD who exhibit with concentration problems.  It’s delivered through an immersive video game experience on mobile device ("EndeavorRx," 2024).

This new digital health care innovation improves the attention span of children. It shows to effectively treat children from ages 8-17 ("EndeavorRx," 2024).

It is designed to be an engaging experience. The gaming system adapts to each child. Lastly, this newly designed medical intervention allows parents to track their child's progress on the EndeavorRx application ("EndeavorRx," 2024).

Reference

Oh, S., Choi, J., Han, D. H., & Kim, E. (2024). Effects of game-based digital therapeutics on attention deficit hyperactivity disorder in children and adolescents as assessed by parents or teachers: a systematic review and meta-analysis. European Child & Adolescent Psychiatry, 33(2), 481–493. https://doi.org/10.1007/s00787-023-02174-z

Akili Interactive Labs. (2024, January 12). EndeavorRx: Prescription treatment for ADHD. https://www.endeavorrx.com/

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Link: https://youtu.be/ULPplvxFqGg?si=P9XSdqKTPyHtekw7

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Accessibility and Affordability: The cost of this digital therapeutic intervention might not be affordable and accessible to everyone.

Limited Research: Even though this treatment is approved by the FDA (Food and Drug Administration), the limited evidence supporting its use is not more established than other notable treatments for ADHD.

Gaming Dependency: The treatment requires the use of a special device. This may not be suitable for all prescribed patients. In return, this may cause a dependency on technology.

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Personalized Treatment Approach: The game is designed to adapt to the user’s performance. This enhances the effectiveness of a modified intervention to the given needs and improvement of each prescribed user.

Prescription Based: This newly innovative technology is supervised and monitored by medical professionals. It allows a level of surveillance. It gives parents a sense of security.

Data monitoring: There is a continuous data monitoring system recording the user’s progress. This allows the prescriber to make informed decisions in relation to the feedback received from the gaming system.

Engaging: This technology is designed to be appealing to children.

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In my opinion, this form of treatment can be a way to decrease drug dependency for those with ADHD. It is not a standalone treatment for this disorder but can show improvement in attentiveness. This can increase performance in schoolwork and increase the likelihood of being able to collaborate with others while in a group setting. As a healthcare professional, there have been instances where patients are dependent on pharmacological treatments for ADHD. If this technology can be implemented in conjunction with other non-medical treatments it may drastically improve the treatment rates of those with ADHD.

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Futuristic

Competition

Restorative

Achiever

Responsibility

The following are my identified five Clifton strengths.

With these strengths it brings qualities to group work that allows a strong foundation for successful outcomes. Strong qualities bring out the best in teamwork.

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Meet the Team: Fernando, Sheila, Pablo, Carter, and Chelsea!

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Fernando: Purpose is to keep the group in FOCUS. It is important to maintain focus while completing extensive projects that require teamwork.

Sheila: serves as our STRATEGIC support. All plans and group collaboration requires a strategic approach. This enhances productive outcomes.

Chelsea: Our lead COMMAND personnel. She gives clear direction to all members. This is crucial in teamwork. It allows specific direction to be executed by each member.

Pablo: P stands for POSITIVITY. Pablo makes sure that the group stays aligned with positive memos. This promotes a conducive work environment.

Carter: Excels at Communication. This allows for effective collaboration and coordination within a team. Clear communication is important in team play.

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Oh, S., Choi, J., Han, D. H., & Kim, E. (2024). Effects of game-based digital therapeutics on attention deficit hyperactivity disorder in children and adolescents as assessed by parents or teachers: a systematic review and meta-analysis. European Child & Adolescent Psychiatry, 33(2), 481–493. https://doi.org/10.1007/s00787-0 23-02174-z

Akili Interactive Labs. (2024, January 12). EndeavorRx: Prescription treatment for ADHD. https://www.endeavorrx.com/