BOSTON– Akili, Inc. (Nasdaq: AKLI), a leading digital medicine company, today released EndeavorOTCTM, a new immersive mobile video game treatment that is clinically proven to improve attention and focus, specifically in adults with ADHD. EndeavorOTC is built on the same technology as Akili’s EndeavorRxⓇ, the world’s first and only FDA-authorized video game treatment now being prescribed for children 8-12 years old with ADHD. EndeavorOTC is now available without a prescription for adults 18 years and older nationwide.
This announcement comes on the heels of recently announced clinical trial data showing that EndeavorOTC (AKL-T01) significantly improved focus, attention, and overall quality of life in adults struggling with ADHD symptoms:
- 83% of participants reported clinical improvements in their focus
- On average, participants’ ability to focus improved by 85%
- Over one-third of participants no longer exhibited an attention deficit following treatment
- 73% of participants reported quality of life improvements, including completing tasks on time, managing multiple tasks at once, and keeping track of important items like wallets or keys
Amid a persistent mental health crisis, an increasing number of adults are seeking help for ADHD symptoms including inattention and lack of focus while facing an ongoing nationwide shortage of ADHD medication. As the gap between demand for care and availability of effective treatments widens, Akili released EndeavorOTC under FDA’s enforcement policy established shortly after the onset of the COVID-19 pandemic to facilitate rapid access to certain low-risk, mental health-related digital health devices.
“Compared with children, adults with ADHD are generally overlooked and under-treated. Current treatments are not sufficient, and adults need more effective options, including non-pharmacological solutions. Untreated ADHD can affect an adult in many adverse ways, from their personal to their professional lives, causing undue stress and other significant mental health challenges,” said Dr. Stephen Faraone, Distinguished Professor and Vice Chair for Research, Department of Psychiatry, SUNY Upstate Medical University and President of the World Federation for ADHD.
“New, easily accessible treatments are needed to effectively support adults with ADHD,” said Duane Gordon, President, Attention Deficit Disorder Association (ADDA). “I’m delighted to see new technology used to develop a unique approach to treatment, and a video game treatment is a fun and engaging way to empower adults with ADHD.”
The release of EndeavorOTC provides immediate access to this clinically-proven non-drug option for those seeking new safe and effective solutions to their treatment needs. The first generation of EndeavorOTC is available now in the Apple App Store® for adults 18 and older with ADHD. Akili will actively involve adults using EndeavorOTC in the ongoing development of the product, gathering feedback that will help shape future generations of the game. By working closely with the community and embracing their perspective, Akili will continue to enhance EndeavorOTC to make the experience even more engaging, enjoyable and impactful.
“Without reliable access to ADHD medication or sufficient mental healthcare professionals to meet demand, millions of Americans are in urgent need of new validated and accessible treatment options. Patients want better, and they want non-drug treatment options,” said Eddie Martucci, chief executive officer of Akili. “The core technology inside EndeavorOTC has helped thousands of children with ADHD, and recently has shown it dramatically helped adults in our clinical trial improve their focus, time management and organizational skills, and their ability to keep track of important items. We’re thrilled to make EndeavorOTC available to adults who can benefit.”
Akili’s Endeavor suite of products, EndeavorOTC and EndeavorRx, combine the best of medicine and mobile gaming and were developed through the collaboration of world-renowned cognitive neuroscientists and acclaimed entertainment and technology designers. The digital treatments run on Akili’s patented Selective Stimulus Management Engine (SSME™) core technology. SSME has been validated in more than a dozen clinical trials across a variety of diseases that impact cognition, including ADHD, depression, multiple sclerosis, and autism spectrum disorder. By completing tasks while simultaneously filtering out distractions, the treatments target areas of the brain responsible for cognitive functions including focus, which helps improve attention and day-to-day functioning. Algorithms adapt to each user in real time, delivering a personalized experience and challenging the user at an optimized level to improve the targeted cognitive function.
