Akili Awaits FDA Feedback On Data Needs For OTC Marketing Of ADHD Digital Therapeutic

 
• By Lauren Nardella

The DTx company’s revenue grew some 500% to $702,000 in the fiscal 2023 third quarter, reflecting its direct-to-consumer launch of EndeavorOTC to adult ADHD patients in June under a US FDA enforcement policy established for digital health devices during the COVID-19 public health emergency. That policy has since sunset, and Akili has submitted a 510(k) application to the agency for review.

• Source: Shutterstock

Adults with attention-deficit/hyperactivity disorder flocked to Akili Inc.’s EndeavorOTC digital treatment during the third fiscal quarter of 2023, showing that pivoting from Rx to an over-the-counter sales model “has fundamentally changed the trajectory of our business,” according to the company.

Boston, MA-based Akili announced on 9 November that EndeavorOTC reached approximately 177,000 downloads and $530,000 in sales in the third quarter

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