Clinical trial data show that 83% of adults with ADHD experienced improved focus, and 73% reported improvement in quality of life after EndeavorOTC treatment
Available nationwide without a prescription, EndeavorOTC users can now access their personalized Focus Score and track progress towards clinically-meaningful improvements in attention.
Akili, Inc. (Nasdaq: AKLI), a leading digital medicine company, today announced that EndeavorOTC™, the mobile video game treatment clinically proven to improve attention and focus in adults with ADHD, is now available on Google Play™ for popular Android devices, including most Samsung Galaxy and Google Pixel models. Out of the estimated 11 million adults living with ADHD in the United States, approximately 40% are Android users so we believe this release represents a crucial step in offering an accessible non-drug treatment option to adults with ADHD, particularly amid the continued stimulant medication shortage and ongoing mental health crisis.
EndeavorOTC is built on the same technology as Akili’s EndeavorRx®, the world’s first and only FDA-authorized video game treatment, for children 8-12 years old with ADHD. In a recent clinical trial, EndeavorOTC significantly improved focus, attention, and overall quality of life in adults struggling with ADHD symptoms. On average, participants’ ability to focus improved by 85%*; over one-third of participants no longer exhibited an attention deficit following treatment*, and 73% of participants reported quality of life improvements**.
“Video games are an established part of life for the majority of American adults,” said Jon David, chief product officer of Akili. “By delivering an ADHD treatment via video game, we believe we’re tapping into established habits and making a clinically-proven treatment more accessible and approachable than ever before. With the launch of EndeavorOTC on Android, we’re continuing to break down barriers to care, making our treatment available to millions of adults who may benefit.”
The release of EndeavorOTC comes at a time when the ADHD community faces continued challenges accessing care. Fueled by manufacturing issues and record-high prescription rates, the stimulant shortage continues and now affects multiple ADHD drugs. Last month, the U.S. Food and Drug Administration (FDA) and the Drug Enforcement Administration (DEA) issued a joint statement on the ongoing nationwide shortage of stimulants for the treatment of conditions such as ADHD, noting the FDA’s support of non-drug treatment options including Akili’s EndeavorRx product.
The Android release follows EndeavorOTC’s release on the Apple iOS App Store® in June 2023. EndeavorOTC now features Akili’s recently released Focus Score, a new metric for users. Focus Score provides a measurement of how quickly and accurately patients can complete a task despite distractions during gameplay, assisting with setting benchmarks and quantifying progress. A patient’s personalized baseline Focus Score is calculated during treatment onboarding, along with a target Focus Score that serves as a treatment goal. In Akili’s recent adult ADHD clinical trial, Focus Score improvements were directly related to improvement in ADHD-related symptoms and overall quality of life—things like being able to complete tasks or keep track of important items like your wallet and keys.
*As measured by an improvement ≥ 1.4 on the TOVA® ACS. Changes in the Focus Score are statistically significantly related to changes in TOVA and other outcomes. Treatment results may vary. Internal data on file.
**As measured by the validated Adult ADHD Quality of Life Scale (AAQoL). Internal data on file.
About EndeavorOTC and EndeavorRx
Akili’s suite of cognitive treatment products for ADHD includes EndeavorOTC and EndeavorRx.
EndeavorOTC is a digital therapeutic indicated to improve attention function, ADHD symptoms and quality of life in adults 18 years of age and older with primarily inattentive or combined-type ADHD. EndeavorOTC utilizes the same proprietary technology underlying EndeavorRx, a prescription digital therapeutic indicated to improve attention function in children ages 8-12. EndeavorOTC is available under the U.S. Food and Drug Administration’s current Enforcement Policy for Digital Health Devices for Treating Psychiatric Disorders During the Coronavirus Disease 2019 (COVID-19) Public Health Emergency. EndeavorOTC has not been cleared or authorized by the U.S. Food and Drug Administration for any indications. It is recommended that patients speak to their health care provider before starting EndeavorOTC treatment. No serious adverse events have been reported in any of our clinical studies. To learn more, visit EndeavorOTC.com.
EndeavorRx is indicated to improve attention function as measured by computer-based testing in children ages 8 to 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. EndeavorRx is available by prescription only. It is not intended to be used as a stand-alone therapeutic and is not a substitution for a child’s medication. The most common side effect observed in children in EndeavorRx’s clinical trials was a feeling of frustration, as the game can be quite challenging at times. No serious adverse events were associated with its use. EndeavorRx is recommended to be used for approximately 25 minutes a day, 5 days a week, over initially at least 4 consecutive weeks, or as recommended by your child’s health care provider. To learn more about EndeavorRx, please visit EndeavorRx.com.
Akili is pioneering the development of cognitive treatments through game-changing technologies. Akili’s approach of leveraging technologies designed to directly target the brain establishes a new category of medicine – medicine that is validated through clinical trials like a drug or medical device, but experienced like entertainment. Akili’s platform is powered by proprietary therapeutic engines designed to target cognitive impairment at its source in the brain, informed by decades of research and validated through rigorous clinical programs. Driven by Akili’s belief that effective medicine can also be fun and engaging, Akili’s products are delivered through captivating action video game experiences. For more information, please visit www.akiliinteractive.com.
Cautionary Note Regarding Forward-Looking Statements
This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995, as amended. These forward-looking statements generally are identified by the words “believe,” “project,” “expect,” “anticipate,” “estimate,” “intend,” “strategy,” “future,” “opportunity,” “plan,” “may,” “should,” “will,” “would,” “will be,” “will continue,” “will likely result,” and similar expressions. Forward-looking statements are predictions, projections, and other statements about future events that are based on current expectations and assumptions and, as a result, are subject to risks and uncertainties.
These forward-looking statements include, without limitation, statements in this press release related to: the ability of adults to access and use EndeavorOTC; the ability of EndeavorOTC to improve attention function, ADHD symptoms and quality of life in adults with ADHD; and the growing need for ADHD treatment and non-drug options. Any forward-looking statements in this press release are based on management’s current expectations and beliefs and are subject to a number of risks, uncertainties, and important factors that may cause actual events or results to differ materially from those expressed or implied by any forward-looking statements contained in this press release, including, without limitation, risks and uncertainties related to: the risk that prior results, such as signals of efficacy or safety observed from clinical trials will not continue or be repeated in EndeavorOTC or our ongoing or planned clinical trials for this or any other product, or will be insufficient to support regulatory submissions or to obtain, support or maintain marketing approval in the United States or other jurisdictions, or that long-term adverse safety findings may be discovered; the risk that our products will not be further developed or commercialized successfully; the timing and results expected from our and our partners’ clinical trials and our reliance on third parties for certain aspects of our business; our ability to accurately estimate expenses, capital requirements, and needs for additional financing; and other risks identified in our current filings and any subsequent filings made with the Securities and Exchange Commission (SEC). We caution you not to place undue reliance on any forward-looking statements, which speak only as of the date hereof and should not be relied upon as representing the company’s views as of any subsequent date. We disclaim any obligation to publicly update or revise any such statements to reflect any change in expectations or in events, conditions, or circumstances on which any such statements may be based, or that may affect the likelihood that actual results will differ from those set forth in the forward-looking statements.