Following positive top-line data released in May, Akili Interactive announced it will release its video game treatment for attention deficit hyperactivity disorder to adults who want to use it.
EndeavorOTC, an adult version of Akili’s Food and Drug Administration-cleared video game for children, is now live in the Apple App Store and can be accessed without a consultation with a doctor or a prescription. Akili plans to submit the app for FDA clearance at a later date and is launching it now under an April 2020 FDA enforcement policy released in response to the Covid-19 pandemic. Under the policy, companies were allowed to launch digital treatments for certain psychiatric conditions without seeking clearance from the agency. Following the end of the official public health emergency last month, the policy will be lifted in November, affording Akili a limited window to experiment with the product in the real world ahead of its FDA submission.
In particular, Akili is still debating whether to ultimately submit the app for clearance as a prescription app, or to submit it for clearance as an over-the-counter treatment. The company will also be testing multiple prices randomized to different users to see what people are willing to pay, as well as testing monthly and longer subscriptions. Shortly after launch, the application showed $29 for a monthly subscription, $50 for a subscription billed every two moths, and $99 for a year of access. But those prices could change for different users.
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