FDA Clears Akili’s EndeavorOTC as Over-the-Counter ADHD Treatment

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Key Highlights

  • FDA clearance of EndeavorOTC for adult ADHD treatment.
  • Engaging video game experience to improve attention function.
  • Available over-the-counter on Apple App Store and Google Play Store.
  • 83% of participants reported improved focus in clinical trials.
  • No serious adverse events reported.

Source: Business Wire

Notable Quote

  • “This FDA authorization of EndeavorOTC positions it as a scientifically and clinically validated digital therapy for adult ADHD patients, and we’re incredibly proud of pioneering a new tier of digital medicine. This is the culmination of years of clinical studies and the collective effort of scores of technical, scientific, clinical, and regulatory professionals. We are particularly grateful to the patients who participated in the study that made this clearance possible.”  Matt Franklin, Chief Executive Officer at Akili

SoHC's Take

The FDA clearance of Akili’s EndeavorOTC marks a significant advancement in the treatment of ADHD. As the first over-the-counter digital therapeutic for ADHD, EndeavorOTC leverages innovative technology to offer an engaging and effective solution for adults with attention issues. The rigorous clinical studies supporting this clearance highlight the product’s efficacy and safety, making it a valuable addition to the ADHD treatment landscape. Akili’s commitment to combining fun with therapeutic efficacy sets a new standard in digital medicine, offering patients a novel approach to managing their condition.

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