FDA Clears First Prescription Game-Based Treatment Device for Children With ADHD

June 17, 2020
Jennifer Barrett
Jennifer Barrett

EndeavorRx (Akili Interactive), a prescription-only game-based device, is indicated for use in children ages 8 to 12 years old with primarily inattentive or combined-type ADHD who have demonstrated an attention issue.

Officials with the FDA have cleared the first game-based digital therapeutic device for children with attention deficit hyperactivity disorder (ADHD), according to a press release.1

EndeavorRx, a prescription-only game-based device, is indicated for use in pediatric patients ages 8 to 12 years old with primarily inattentive or combined-type ADHD who have demonstrated an attention issue. The FDA granted marketing authorization for the device to Akili Interactive. EndeavorRx is intended for use as part of a therapeutic program that may include clinician-directed therapy, medication, and/oreducational programs.1

According to Akili Interactive, EndeavorRx uses a captivating video game experience to improve attention impairments, which are a key component of ADHD for many children. The device is designed to directly target and activate neural systems through sensory stimuli and motor challenges to improve cognitive functioning.2

The FDA’s decision to grant clearance was based on data from 5 clinical studies in more than 600 pediatric patients with ADHD. Results from the pivotal prospective, randomized, controlled STARS-ADHD study published in The Lancet Digital Health showed that EndeavorRx improved objective measures of attention in children with ADHD. The study included 348 children diagnosed with ADHD.2

According to the study, after 4 weeks of treatment, one-third of children no longer had a measurable attention deficit on at least 1 measure of objective attention. Additionally, approximately half of parents observed a clinically meaningful change in their child’s day-to-day impairments after 1 month of using the device. Moreover, this increased to 68% after a second month of treatment. Following a month of treatment, improvements in ADHD impairments were maintained for up to 1 month.2

The clinical research program also included the STARS-ADJUNCT and ADHD-POC studies, as well as 2 pilot trials in ADHD with different comorbidities. In the STARS-ADJUNCT open-label study, statistically significant improvement was seen in a parent-reported clinician-administered scale of ADHD impairments, called IRS, from baseline to after 4 weeks of treatment in both children on stimulants and off any ADHD medication.2

Some participants experienced non-serious treatment-related adverse events with EndeavorRx, including frustration, headache, dizziness, emotional reaction, nausea or aggression.2

“For children living with ADHD, improving their ability to focus and resist distraction is critical to their daily functioning and performance in school,” Elysa Marco, MD, cognitive and behavior child neurology and clinical executive for neurodevelopmental medicine at Cortica Healthcare, said in a statement.2 “Unlike traditional ADHD medications, EndeavorRx is designed to specifically target inattention. Based on the benefits of my research participants and patients have experienced, I am thrilled that EndeavorRx is moving from the lab to the clinic to play an essential role as part of a comprehensive treatment plan for children with ADHD.”

The EndeavorRx treatment will be available with a prescription to families soon, according to Akili. The device will be released as the centerpiece of the Endeavor Care Program, which includes the EndeavorRx treatment and Akili Care, a mobile tracking app and personal support services for caregivers.2

References

1. FDA Permits Marketing of First Game-Based Digital Therapeutic to Improve Attention Function in Children with ADHD. News Release. FDA; June 15, 2020. Accessed June 17, 2020. https://www.fda.gov/news-events/press-announcements/fda-permits-marketing-first-game-based-digital-therapeutic-improve-attention-function-children-adhd.

2. Akili Announces FDA Clearance of EndeavorRx for Children with ADHD, the First Prescription Treatment Delivered Through a Video Game. News Release. Akili Interactive; June 15, 2020. Accessed June 17, 2020. https://www.akiliinteractive.com/news-collection/akili-announces-endeavortm-attention-treatment-is-now-available-for-children-with-attention-deficit-hyperactivity-disorder-adhd-al3pw.