In response to U.S. stay-at-home orders, the FDA has cleared the way for the emergency release of several validated digital therapeutics including Endeavor™ (AKL-TO1), a digital attention treatment from Akili Interactive. Endeavor™, a computer game experience that aims to improve attention function in children ages 8-12 with primarily inattentive or combined-type ADHD, is now available for free to eligible patients.

The Food and Drug Administration (FDA) has cleared the way for accelerated public release of several validated digital devices for treating psychiatric disorders during the pandemic.¹ Endeavor™ (AKL-TO1), from Akili Interactive, is one of several low-risk, clinically validated therapeutics that is now being made available, though without formal FDA clearance, for a limited time during the crisis.² Akili has been working with the FDA on approval of Endeavor™ as a prescription treatment for use in pediatric ADHD. The treatment has been evaluated in more than 600 children with ADHD across five clinical studies.

A study was recently published providing evidence that AKL-T01 might be used to improve objectively measured inattention in paediatric patients with ADHD, while presenting minimal adverse events.

Endeavor™ is based on a game called NeuroRacer, which was designed by neuroscientist Adam Gazzaley, M.D., Ph.D., Akili’s chief science advisor and founding director of the neuroscience center at University of California, San Francisco. The game is played on a tablet and uses specialized algorithms to increase or decrease difficulty depending on a player’s performance. The goal is to keep children with ADHD challenged but not overloaded to stimulate specific areas of the brain and improve attentional control, says Akili CEO Eddie Martucci, Ph.D.

Endeavor™ is available to families of children aged 8-12 who have been diagnosed with ADHD. A formal prescription isn’t currently required due to restrictions placed on families during quarantine, but parents should talk with their child’s physician before use. Anyone that is eligible — per Akili Interactive clinical indication and instructions for use — can access Endeavor™ and have the cost waived for a limited time. At this time, Endeavor™ is only available in the United States.

To check eligibility, caregivers should visit Akili’s enrollment site at www.GetEndeavor.com.

Sources

¹“Enforcement Policy for Digital Health Devices For Treating Psychiatric Disorders During the Coronavirus Disease 2019 (COVID-19) Public Health Emergency.” Food and Drug Administration (Apr. 2020). https://www.fda.gov/regulatory-information/search-fda-guidance-documents/enforcement-policy-digital-health-devices-treating-psychiatric-disorders-during-coronavirus-disease

²“Akili Announces Endeavor™ Digital Attention Treatment is Now Available for Children with Attention Deficit Hyperactivity Disorder (ADHD) under FDA’s COVID-19 Enforcement Discretion Guidance.” Akili (Apr. 2020). https://www.akiliinteractive.com/news-collection/akili-announces-endeavortm-attention-treatment-is-now-available-for-children-with-attention-deficit-hyperactivity-disorder-adhd