For Healthcare Professionals

EndeavorRxTM is the first-and-only FDA-cleared prescription treatment for inattention in children with ADHD delivered through a digital therapy

Now your patients can play their medicine

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.

9.3% of subjects experienced side effects, including frustration, headache, dizziness, emotional reaction, nausea or aggression.

*EndeavorRx is only available to your patients through a prescription, and is not intended as a stand-alone therapeutic or a substitute for your patient’s medication.


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Prescribing EndeavorRx

EndeavorRx is delivered through an immersive and challenging treatment experience

EndeavorRx is designed to improve attentional control by strengthening focus, interference processing and multitasking, which helps to avoid interruptions, distractions, and irrelevant information and achieve goals. This is made possible by the Selective Stimulus Management Engine (SSMETM), the technology behind EndeavorRx.

The Selective Stimulus Management Engine (SSME), is a proprietary & patented technology that presents specific sensory stimuli and simultaneous motor challenges designed to target key neural systems in the brain related to attentional control.

SSME implements specific closed-loop algorithms that adapt real-time and between treatment sessions to automatically adjust the difficulty level for a personalized treatment experience. The algorithms enable second by second monitoring of patient progress, and continuously challenges each patient to an optimized level, encouraging them to improve their performance.

The game layer built on top of the SSME Engine was designed by industry leading game designers to create a fun, age appropriate experience for the child, using built-in game rewards, missions, levels, and storytelling to help support the child to stay engaged with their treatment. Nevertheless, EndeavorRx can be perceived as challenging at times:

  • The game mechanics might feel repetitive for some children
  • The algorithm continuously adapts its difficulty as the child gets better. This means that there is not a way to ‘win’ EndeavorRx. It will continue to feel challenging
  • Finally, it might be hard for the child or family to stick to a daily routine

Therefore, the treatment requires commitment by the family and child.

Download EndeavorRx to try a demo.

The demo lasts for about 5 minutes and gives a feel for the game action. It provides a non-therapeutic experience with neither anticipated clinical benefit nor expected adverse events. The demo allows you to play an unlimited number of times but it will always start with the introductory instructions and no gameplay information will be saved. A compatible Apple device is needed to play the demo. Note: as the demo is designed to be non-therapeutic it should not be used as a substitute for the actual EndeavorRx treatment.

To give it a try - simply download EndeavorRx from the App Store. No signup or identifying information is required. Feel free to share this link with colleagues and patients as appropriate.

With EndeavorRx, you can do more

A new clinically validated, non-medication option is now in your armamentarium.

In the STARS-ADHD*** pivotal trial, EndeavorRx achieved the primary endpoint, with a mean change in the TOVA® API (Attention Performance Index) of 0.93, significant compared to a digital control (p=0.006)*

**The TOVA® - Test of Variables of Attention - is an FDA-cleared objective, computerized continuous performance test measuring attention and inhibitory control, and can aid in the diagnosis and treatment evaluation of ADHD.

**The TOVA® API (Attention Performance Index) (also known as TOVA® ACS: Attention Composite Score) is a composite measure that captures attentional functioning at a broad scale, including aspects of sustained and selective attention.

***STARS-ADHD Study Design: a randomized, double-blind, parallel-group, 4-week, controlled trial of AKL-T01 in children aged 8-12 years old with ADHD (not taking ADHD medications) and TOVA® API baseline scores of ≤ −1·8 (indicating impaired attention function) conducted at 20 sites in the USA. 348 subjects were randomly assigned to receive EndeavorRx (AKL-T01) (n=180) or digital control (n=168) for approximately 25 minutes per day, 5 days per week, for 4 weeks.

In the STARS-Adjunct open-label study, 206 children aged 8-14 years with ADHD were studied in 2 cohorts: 1) Children Treated with ADHD stimulant medication (On Stimulants, n=130) & 2) Children not treated with any ADHD medication (No Stimulants, n=76).

Both groups were instructed to play EndeavorRx for approximately 25 minutes per day, 5 days per week, over two 4-week treatment periods, separated by a 4-week treatment pause.

After the first 4-week treatment, IRS overall severity score was significantly improved for both the On Stimulants (-0.7, p<0.001) and No Stimulants (-0.5, p<0.001) cohorts compared to baseline. ADHD-RS (Total, Inattentive and Hyperactive subscales) and CGI-I were also significantly improved for both cohorts compared to baseline at day 28 and further improved with an additional treatment month (baseline to after the second 4-week treatment).

Treatment with EndeavorRx demonstrated consistent improvements in ADHD symptoms (as measured by ADHD-RS) across our 5 clinical studies, with responder rates (based on a threshold of clinically meaningful change) ranging from 23-36% for one month of treatment to 45% after two months of treatment.

*ADHD-Rating Scale (ADHD-RS), is a ADHD symptoms rating scale. It consists of 18 questions corresponding directly to the DSM symptom criteria for ADHD and offers subscales for the assessment of inattention/hyperactivity-impulsivity.

**The IRS: Impairment Rating Scale measures parent-reported ADHD-related impairment across domains such as social functioning, academic progress, and self-esteem, including an overall impairment.

Of 538 participants using EndeavorRx in clinical trials, 50 participants (9.3%) experienced treatment-related adverse events, most commonly frustration (6.1%), headache (1.3%), dizziness (0.6%), emotional reaction (0.4%), nausea (0.4%), and aggression (0.2%). All adverse events were generally transient and there were no serious adverse events reported.

Identifying patients

HCPs are advised to use our indications for characteristics of our trial participants as a benchmark to assess the types of patients who may derive benefit from EndeavorRx treatment.

EndeavorRx is indicated for children ages 8-12 with primarily inattentive or combined-type ADHD, and have demonstrated attention issues.

EndeavorRx should be considered as part of a therapeutic program, and can be administered alongside other therapies.

When identifying suitable patients, discussing the time commitment upfront and assessing whether the commitment seems feasible for a family at a particular time (taking into account other factors like school commitments) is advisable.

If EndeavorRx is appropriate for your patients, the prescription process will be quite unique to you, the caregiver and the patient.

As far as how your patients should be treated, in the initial clinical trials, each patient played EndeavorRx for approximately 25 minutes per day, 5 days per week, for 4 weeks.

Additionally, a more recent clinical trial demonstrated that a second month of Endeavor treatment can lead to increased benefits. In that trial, EndeavorRx was provided to children for one month, with a month off, followed by a second month of treatment. After this second month of treatment, the data indicates further and continued improvement beyond the first month. Each patient played EndeavorRx for approximately 25 minutes per day, 5 days per week during each 4 week treatment period.

About 50% of parents saw a clinically meaningful change in their child’s day to day impairments after one month of treatment with EndeavorRx; this increased to 68% after a 2nd month of treatment.

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

With a prescription of EndeavorRx your patients also receive access to Akili CareTM

Akili Care includes:

The EndeavorRx prescription process is made easy through support by Akili Assist®

Fax the completed prescription enrollment form to Akili Assist

If your patient does not bring in a prescription enrollment form, you can download it here and complete it together.

Once the prescription is submitted, our Akili Assist support team will handle all of the necessary steps for you.

Upon completion of the onboarding process, your patient will download EndeavorRx in the App Store and use the code that's emailed to them to activate treatment.

Please note:

  • EndeavorRx is only available to your patients through a prescription, and should not be used as a stand-alone therapy or substitute for your patient’s medication
  • EndeavorRx is only available with iOS devices
  • 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

If you'd like to be informed of updates to EndeavorRx, join our email list.

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.

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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, Tests 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.