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The FDA has authorized "EndeavorOTC" for treating attention-deficit/hyperactivity disorder (ADHD) in adults, marking a milestone as the first OTC digital therapy approved for this purpose.

Available for download in the United States via the Apple App Store and Google Play Store, "EndeavorOTC" — developed by Akili Interactive — aims to address symptoms associated with adult ADHD.

Akili initially gained FDA approval for "EndeavorRx," a version tailored for children with ADHD, in June 2020. The decision followed a study showing significant clinical improvements in 68% of children after two months of usage, as detailed in The Lancet Digital Health journal. "EndeavorRx" is recommended for daily use, 25 minutes per session, five days a week over at least four weeks.

Adult ADHD manifests with deficits in the brain's executive function, impacting organizational skills, attention span, and impulse control. While hyperactivity is more prevalent in men, women often exhibit inattentive symptoms, leading to potential misdiagnosis or delayed diagnosis.

As per Managed Healthcare Executive, the STARS-ADHD-Adult clinical trial enrolled 221 adults who used "EndeavorOTC" over six weeks, reporting an 83% improvement in attention control scores measured by the TOVA. Additionally, 72% noted enhanced quality of life based on the Adult ADHD Quality of Life Scale (AAQoL), with 45.8% achieving clinically meaningful improvement.

Minor adverse effects, such as nausea (1.8%) and headaches (1.4%), were reported by participants, showing "EndeavorOTC's" overall tolerability.

According to Akili, "'EndeavorOTC' is not intended to be a replacement for any form of treatment and should be used as part of a therapeutic program that may include clinician-directed therapy, medication, and/or educational programs, which further address symptoms of the disorder."

Akili further cautioned "that patients seek care from a medical health care provider in conjunction with its use."

This development marks a strategic shift for Akili towards non-prescription digital therapies, aimed at reducing dependence on insurers and expanding market reach. Last year, the company underwent restructuring efforts, including a significant workforce reduction.