EndeavorRx, 1st and Only Prescription Video Game Treatment, Secures FDA Label Expansion

 Akili’s Clinically Proven Digital Medicine Now Authorized for Children 8-17, Opening Option to More Patients as Ongoing Stimulant Shortage Persists

Akili, Inc. (Nasdaq: AKLI), a leading digital medicine company, today announced that it has received authorization from the U.S. Food and Drug Administration (FDA) to expand the label for EndeavorRx^® from 8 to 12 year-old patients with primarily inattentive or combined-type ADHD who have a demonstrated attention issue to include older children aged 13 - 17. This increased age range is expected to more than double the number of pediatric patients with ADHD who are now eligible for EndeavorRx – the only FDA-authorized, game-based digital therapeutic – with a prescription from a healthcare provider. (Akili also offers a non-prescription product for adults with ADHD, using the same technology, EndeavorOTC™.)

The clinical study on which the FDA’s label expansion authorization for EndeavorRx is based involved 162 adolescents with a verified diagnosis of inattentive or combined-type ADHD who all received EndeavorRx for 4 weeks and subsequently demonstrated significant improvements in TOVA^Ⓡ-measured* attentional control.

https://investors.akiliinteractive.com/news/news-details/2023/EndeavorRx-Worlds-First-and-Only-Prescription-Video-Game-Treatment-Secures-FDA-Label-Expansion-for-Pediatric-ADHD-Patients-Aged-13-17/default.aspx