The Food and Drug Administration (FDA) has cleared EndeavorRxTM (AKL-T01; Akili Interactive) for use as a prescription-only video game-based digital therapeutic to improve attention function in pediatric patients aged 8-12 years with primarily inattentive or combined-type attention-deficit hyperactivity disorder (ADHD).

EndeavorRx utilizes the Company’s proprietary Selective Stimulus ManagementTM engine to distribute sensory and motor stimuli to target and activate the prefrontal cortex of the brain through an action video game experience. To help manage ADHD symptoms, the device can be used as part of a therapeutic program that may include clinician-directed therapy, medication, and/or educational programs. 

The FDA granted clearance based on data from 5 clinical studies in more than 600 children with ADHD, including the pivotal STARS-ADHD study that evaluated the efficacy and safety of EndeavorRx in 348 pediatric patients aged 8 to 12 years with a confirmed diagnosis of ADHD. Patients were randomized to receive either EndeavorRx or a digital control intervention. The primary outcome was the mean change in Test of Variables of Attention (TOVA®) Attention Performance Index (API) from pre-intervention to post-intervention. 

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Findings from the study showed that treatment with EndeavorRx resulted in a statistically significant improvement from baseline in TOVA API compared with control (P =.006). Additionally, findings from the open-label STARS-ADHD Adjunctive study showed that EndeavorRx was associated with a statistically significant improvement in Impairment Rating Scale (a parent-reported clinician-administered scale of ADHD impairments) after the first and third month of treatment both in children on stimulant medication and off any ADHD medication (P <.001).

With regard to safety, EndeavorRx was found to be well tolerated. The most common adverse events reported were headache, frustration, dizziness, emotional reaction, and aggression.

“The EndeavorRx device offers a non-drug option for improving symptoms associated with ADHD in children and is an important example of the growing field of digital therapy and digital therapeutics,” said Jeffrey Shuren, MD, JD, director of the FDA’s Center for Devices and Radiological Health. 

EndeavorRx will be available soon for download from the App Store on mobile devices. The Company will also release the Endeavor Care Program, which includes EndeavorRx and Akili CareTM, a mobile tracking app and personal support services for caregivers. 

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This article originally appeared on MPR