BOSTON - Akili, Inc. (NASDAQ: AKLI), a digital medicine company, has announced that its Japanese partner, Shionogi & Co. Ltd, has submitted a request for marketing approval in Japan for SDT-001, a digital therapeutic aimed at improving attention in children with ADHD.
SDT-001 is a localized version of Akili's EndeavorRx, the first prescription digital therapeutic for pediatric ADHD authorized by the FDA in the United States.
The submission is based on positive results from a Phase 3 clinical trial conducted in Japan. The trial involved 164 pediatric ADHD patients aged 6 to 17 who were receiving conventional treatments. Those treated with SDT-001 showed statistically significant improvements in attention scores over a control group after six weeks. No serious adverse events related to the treatment were reported.
Dr. Scott Kollins, Akili's Chief Medical Officer, emphasized the significance of this milestone, which could provide a new treatment option in Japan, where some pharmaceutical therapies are not as accessible for pediatric ADHD patients.
Akili's suite of cognitive treatment products, including EndeavorRx for children and EndeavorOTC for adults, utilizes proprietary technology to target cognitive impairment. EndeavorRx is available by prescription and is intended to be part of a comprehensive therapeutic program. The most common side effect observed was frustration due to the game's challenging nature.
This submission to Japan's Ministry of Health, Labor, and Welfare is a step towards expanding the availability of Akili's digital therapeutics to international markets. The company's vision is to create treatments that are clinically validated yet engaging, redefining the concept of medicine through technology.
The information reported is based on a press release statement from Akili, Inc.
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