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EndeavorRx®: A Digital Therapeutic for ADHD

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As you may have heard, there is now an FDA-approved digital therapeutic option for ADHD. In this blog post, we’re going to define digital therapeutics; discuss the product; identify the patient population who may benefit most from its use; describe how to best use the intervention; and discuss potential benefits, harms, limitations, and costs inherent to the product.

EndeavorRx®: A Digital Therapeutic for ADHD

The Digital Therapeutics Alliance defines a digital therapeutic (DTx) as a “health [software] intended to treat or alleviate a disease, disorder, condition, or injury by generating and delivering a medical intervention that has a demonstrable positive therapeutic impact on a patient’s health.”1 A DTx could thus take the form of a web page, program, or other software application that is intended to help with the management of a disease or condition.

On June 15, 2020, the US Food and Drug Administration permitted the marketing of the game-based DTx medical device EndeavorRx®.2 The product is indicated to improve attention in 8 to 17-year-old patients with inattentive or combined-type ADHD, and the product’s documentation refers to it as a prescription-only “software-as-medical device (SaMD) that resides on the user’s mobile device and can be executed at home.”3 In essence, the device is a smartphone or tablet app that is intended to help children and adolescents with ADHD improve their attention.

At present, the device is available for download on Android and iOS devices.4 The device is a racing or driving game, where the primary inputs are steering, which is done by tilting the hardware that is running the software, and tapping the hardware’s touchscreen.4 The product’s audiovisuals are designed to facilitate engagement, and the product’s “adaptive algorithm” continually adjusts the level of difficulty that the patient encounters with the software,3 in an apparent attempt to attract, retain, and build attention.

The device’s manufacturer states that the device should be used for 25 minutes of training each day, five days a week, for four consecutive weeks.4 Distractions should be minimized while using the device: the manufacturer recommends that the device be used in a quiet room with headphones and without other mobile devices and televisions.4 Patients should know that the device will be challenging to use.4

Benefits of Use

The device has been studied in at least three clinical trials: two studies supporting its use in patients aged 8 to 12 and one study supporting its use in patients aged 13 to 17.3,4 The first study was a randomized, double-blind, digital controlled study in children aged 8 to 12; participants received either the device or a comparator device that used a word search exercise.5 The primary outcome in this study was the change in the Test of Variables of Attention (TOVA) Attention Performance Index (API).5 Briefly, TOVA API is an electronic assessment of the ability to quickly and correctly respond to visual input on a screen over a period of approximately 20 minutes.5 In this study, individuals who used the device had a statistically significant improvement of approximately 1 unit on the TOVA-API at day 28.5 The second study was in a similar population, but the device was used for 1 month, then paused for one month, then used again for one month; of note, this study compared children who were on stimulants to children who were not on stimulants.6 The primary outcome in this study was the ADHD Impairment Rating Scale (IRS), a parent-rated 1 to 7 visual analog scale; in this study, both the stimulant and no-stimulant cohorts showed an improvement of approximately 0.5 to 0.7 points on the IRS by day 28.6 The study of adolescents with ADHD was a single-arm open-label study of individuals aged 13 to 17, with a reported improvement of approximately 2.6 on the TOVA attention comparison score after 4 weeks of treatment.3

Potential Harms, Risks

According to information submitted to the FDA, no serious adverse events were reported in preapproval trials.3 Some 10% of participants in preapproval trials may have experienced a treatment-related adverse event, including decreased frustration tolerance (in approximately 2% of participants) and headache (in approximately 1% of participants).3 Less common adverse events included dizziness, nausea, aggression, and emotional disorder.3 Of note, individuals with photosensitivity or other known sensitivities to playing video games (e.g., motion sickness) were excluded from preapproval studies, as were individuals with a history of non-febrile seizures.3 The manufacturer cautions against use in individuals with photosensitive epilepsy.3,4 The manufacturer recommends pausing use if a patient experiences “emotional reaction, dizziness, nausea, headache, eye-strain, or joint pain” while using the device, and to discontinue use if a patient experiences a seizure.4 The manufacturer recommends using the device “right before bedtime to avoid risk of potential reduction in sleep quality.”4

Limitations of Use and Costs

As discussed previously, the device is approved to improve attention in patients aged 8 to 17 with a diagnosis of inattentive or combined-type ADHD; its possible benefit in other populations, including older patients, younger patients, and patients with predominantly hyperactive-type ADHD, is less clear. Additionally, the device requires a smartphone or other internet-connected touchscreen-based device that the patient can use for approximately 30 minutes a day, multiple days a week. The device is best used in distraction-free environments, and it may not be suitable for patients with low frustration tolerance or a history of property-directed aggression. Further, the device may require a level of hand-eye coordination, and the manufacturer states that the device may not be appropriate for patients with colorblindness or “physical limitations that restrict use of a mobile device.”4

At the time of writing, the cost of EndeavorRx is $99 per 30 days; the cost of treatment may be Flexible Spending Account (FSA)/Health Savings Account (HSA) eligible.7 As this product is a medical device and not a prescription medication, prior authorization and billing may need to occur through the patient’s medical benefits, as if the product were a piece of durable medical equipment.

Conclusions

The EndeavorRx is a software-as-medical-device product that can be downloaded and used on mobile phones and other touchscreen devices. It may help improve symptoms of inattention associated with ADHD. However, it has only been studied in children and adolescents, and its suitability for patients with coordination issues or seizure disorders has not been established. The product is occasionally associated with headaches or frustration. It costs about $100 per month and is intended to be used for about 30 minutes a day, 5 days a week, in a distraction-free setting.

When considering EndeavorRx, patients, caregivers, and prescribers should consider factors including cost, the availability of internet-connected touchscreen devices, and the role that parents would like screen-based devices to play in the patient’s day-to-day life. The device should be considered alongside or as an alternative to other forms of treatment, including behavioral therapy and medication therapy. For your convenience, you can download a printable EndeavorRx® Medical Device Briefing from our expert here.

References

  1. Digital Therapeutics Alliance. What Is a DTx? Accessed Apr 16, 2025. https://dtxalliance.org/understanding-dtx/what-is-a-dtx/
  2. S. Food & Drug Administration. Classification Order: De Novo request DEN200026. Published Jun 15, 2020. Accessed Apr 16, 2025. https://www.accessdata.fda.gov/cdrh_docs/pdf20/DEN200026.pdf
  3. S. Food & Drug Administration. Premarket Notification: 510(k) request K231337. Published Dec 13, 2023. Accessed Apr 16, 2025. https://www.accessdata.fda.gov/cdrh_docs/pdf23/K231337.pdf
  4. Akili Interactive Labs. EndeavorRx® Instructions for Use 5011 (Commercial), Revision U. Updated Jan 2024. Accessed Apr 16, 2025. https://www.hcpendeavorrx.com/wp-content/uploads/2024/01/EndeavorRx-IFU5011-Commercial-RevU.pdf
  5. Kollins SH, DeLoss DJ, Cañadas E, et al. A novel digital intervention for actively reducing severity of paediatric ADHD (STARS-ADHD): A randomised controlled trial. Lancet Digit Health. 2020;2(4):e168-e178. doi:10.1016/S2589-7500(20)30017-0
  6. gov. Software Treatment for Actively Reducing Severity of ADHD in Adolescents (STARS-ADHD-Adolescents) NCT04897074. Updated Aug 14, 2023. Accessed Apr 16, 2025. https://clinicaltrials.gov/study/NCT03649074
  7. Akili Interactive Labs. How to Prescribe – EndeavorRx®. Accessed Apr 16, 2025. https://www.hcpendeavorrx.com/how-to-prescribe/

About the Author

Ron Carico Jr. is a psychiatric clinical pharmacist who practices with Marshall Health in Huntington, West Virginia. He was awarded a doctorate in pharmacy and a master of public health degree from East Tennessee State University in Johnson City, Tennessee. He then went on to complete a two-year fellowship in medication safety and outcomes research with the Veterans Affairs Center for Medication Safety and Center for Health Equity Research and Promotion. As someone with deep roots in the region, he is passionate about putting his training to work to improve the lives of people in Appalachia. His professional interests include mental health conditions, quality improvement, education, and observational research.

General disclaimer:
This content is not intended to address all possible diagnosis methods, treatments, follow up, drugs or their related contraindications or side effects. Standards of practice change as new data becomes available. Therefore, it is strongly recommended that practitioners independently assess and verify diagnosis, treatments and drugs for each individual patient. The authors of the WV ACC guidelines assume no liability for any aspect of treatment administered by a practitioner with the aid of this publication.

Drug disclaimer:
The authors do not endorse or recommend the use of any particular drug mentioned in this publication. Before prescribing a new drug to a patient, practitioners are advised to check the product information accompanying each drug to ensure it is appropriate for a specific patient and to identify appropriate dosage, contraindications, side effects and drug-to-drug interactions.

Standard of care disclaimer:
This publication is not intended to establish a standard of care applicable to practitioners who treated patients diagnosed with ADHD. “Standard of care” is a legal term, not a medical term, which refers to the degree of care a reasonable practitioner would exercise under the same or similar circumstances. The standard of care is a continuum and does not imply optimal care. Practitioner discretion and clinical judgment are paramount and this publication is only intended to aid practitioners’ judgment, not to serve as a substitute for said judgment.