Akili, a digital therapeutics company, recently released EndeavorOTC, an over-the-counter version of their FDA-approved game designed to treat attention deficit hyperactivity disorder (ADHD). While EndeavorOTC is not yet authorized by the FDA for adult use, Akili has announced plans to submit adult clinical trial data this year, which could lead to the approval of EndeavorOTC as an adult ADHD treatment. For just $10 a month, adults can download the game from the iOS App Store and commit to the recommended therapy on their own.
One of the first adults to participate in the EndeavorOTC clinical trial was Barbara Wagner. Wagner had been diagnosed with ADHD a year earlier and was struggling with inattentiveness, especially after retiring. She was initially prescribed a low dose of Adderall, but it wasn’t effective enough. However, increasing the dosage was not an option due to her high blood pressure. Without proper medication, Wagner felt the effects of ADHD returning. When she saw an ad for Akili’s clinical trial, she decided to give it a try.
Despite not being a gamer, Wagner noticed a significant change in her behavior after just a few weeks of playing the game. She found herself calmly finishing the game, cleaning the kitchen, and organizing her office. Her husband even noticed the difference in her behavior. Wagner’s experience is just one example of the potential benefits of digital therapeutics like EndeavorOTC.
Although EndeavorOTC has only been on the market for a short period of time, early results from a clinical trial of 221 adults show promising improvements. About a third of the participants demonstrated improvements on ADHD rating scales, commonly used to assess and diagnose the disorder in adults. Since digital therapeutics like EndeavorOTC aim to retrain the brain and improve focus over time, the effects may not disappear once users stop playing. This makes the treatment comparable to going to the gym – the benefits are enduring, but consistent use is required.
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However, it’s important to note that EndeavorRx, the prescription version of the game for children, and EndeavorOTC are not intended to be standalone solutions for managing ADHD. EndeavorOTC is not yet FDA-cleared, and EndeavorRx is only cleared as an adjunctive treatment. Additionally, while one-third of EndeavorOTC users experienced real-life improvements in their ADHD symptoms, around 70 percent of Adderall users see greater behavioral changes.
Scott Kollins, the chief medical officer at Akili, emphasizes that he would never advise someone to stop taking medication in favor of playing the game. However, with the ongoing shortage of stimulant medications, having an additional low-risk tool like EndeavorOTC can be beneficial. For individuals like Barbara Wagner, who cannot take stimulant medication for various reasons, digital therapeutics offer a welcome alternative. These games adapt to each user’s ability level and provide a treatment option that is accessible and tailored to their needs.
In conclusion, digital therapeutics like EndeavorOTC have the potential to provide adults with ADHD an alternative treatment option. While the game is not yet FDA-approved for adult use, the early results from clinical trials are promising. For individuals who cannot take stimulant medications or struggle to access them, digital therapeutics offer a low-risk, accessible solution for managing ADHD symptoms. As research continues and clinical trial data is submitted to the FDA, it will be interesting to see how digital therapeutics evolve and how they can complement existing treatment options for ADHD.
