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Akili Announces FDA Authorization of EndeavorOTC, the First FDA Clearance of a Digital Treatment for Adults with ADHD Through a Video Game
Akili (Nasdaq: AKLI) has received FDA clearance for EndeavorOTC®, a digital therapeutic game designed for adults with ADHD. This approval marks the first over-the-counter digital treatment for ADHD, improving attention function as verified through clinical trials. EndeavorOTC, available on iOS and Android, effectively enhances attention measures in adults with inattentive or combined-type ADHD. In a study of 221 adults, 83% reported better focus, and nearly 73% noted improved quality of life. The treatment is part of Akili's broader range of digital therapeutics, including EndeavorRx® for children and adolescents. Common side effects included minor nausea and headache, but no serious adverse events were recorded.
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