Akili, a trailblazer in digital therapeutics, has announced the FDA clearance of EndeavorOTC (AKL-T01) as the first over-the-counter treatment for adults with attention-deficit/hyperactivity disorder (ADHD). This groundbreaking digital therapeutic, designed to enhance attention function through an engaging video game interface, targets adults with primarily inattentive or combined-type ADHD, addressing their specific attention deficits.
EndeavorOTC, Akili’s second FDA-approved ADHD therapeutic, stands out as the only digital treatment for ADHD available without a prescription. It is now accessible to users in the United States via the Apple App Store for iOS and the Google Play Store for Android devices.
The FDA’s 510(k) pathway facilitated the review and clearance of EndeavorOTC. The clinical trial underpinning this approval included 221 adults diagnosed with inattentive or combined-type ADHD. Participants engaged with AKL-T01 for six weeks. Results demonstrated significant improvements: 83% reported enhanced focus based on the TOVA attentional control score. Additionally, 72.5% experienced better quality of life, as indicated by the Adult ADHD Quality of Life Scale (AAQoL), with 45.8% achieving clinically meaningful improvements.
Further findings revealed that those using AKL-T01 showed substantial gains in clinician-rated ADHD symptoms, with notable reductions in the ADHD-RS inattention subscale and total scores (p<0.0001). The responder analysis indicated that 32.7% of participants exhibited at least a 30% reduction in the ADHD-RS total score, surpassing the results from previous studies on adolescents and children with ADHD. Specifically, the STARS-ADHD-Adolescents study recorded a 27.1% reduction, while the STARS-ADHD study in children aged 8-12 showed a 24% reduction.
Among the trial participants, 11 individuals (5%) reported mild adverse events, primarily nausea (1.8%) and headaches (1.4%). Importantly, no serious adverse events were recorded.
With EndeavorOTC’s FDA clearance, Akili reinforces its position at the forefront of digital healthcare innovation, offering a novel approach to managing ADHD symptoms.
