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.
If you’d like to be informed of updates to EndeavorRx, join our email list
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 (SSME™), 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)*
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.
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.
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 Care™
Using EndeavorRx in your Practice
Prescriptions can be sent to Phil pharmacy through your EHR found as PhilRx (Columbus, Ohio). If you cannot send prescriptions to Phil through EHR, you can call them directly at 855.977.0975 (Press 1) to provide the prescription over the phone or to obtain a form to fax to 888.975.0603.
To minimize callbacks, please include:
- Diagnosis / Primary ICD-10 code (F90.0 Attention-deficit hyperactivity disorder, predominantly inattentive type; F90.2 Attention-deficit hyperactivity disorder, combined type; F90.8 Attention-deficit hyperactivity disorder, other type; F90.0 Attention-deficit hyperactivity disorder, unspecified type)
- Instructions to play EndeavorRx per the Instructions For Use (IFU)* or other frequency of time per day, days per week, number of weeks, and length of break (if any)
- Number of refills
*IFU Recommendation: 25 mins/day, 5 days/week for 4 weeks with a break of up to 4 weeks, followed by another 4 weeks of 25 mins/day, 5 days/week
Once EndeavorRx treatment has been prescribed for your patient, the caregiver will receive a text message from Phil pharmacy with instructions on next steps.
Meanwhile, prescribers should submit prior authorizations to CoverMyMeds®. Phil pharmacy will initiate the prior authorization and send a key.
03: Treatment Activation
Once the caregiver has processed payment, they will receive a pharmacy-issued activation code via text and email. Caregivers can download the EndeavorRx app from the Apple App Store and apply the activation code to begin treatment.
What’s next? The caregiver should follow up with you during and after treatment cycles to discuss results and next steps, same as after receiving a drug prescription.
Questions? Contact Phil Pharmacy’s HCP Support at: 855.977.0975 (Press 2) or email [email protected]
- EndeavorRx is only available to 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 iPhone or iPad iOS (Apple) devices
- EndeavorRx may not be appropriate for patients with photosensitive 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.
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.
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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For Healthcare Professionals
Getting Started With EndeavorRx™