AKILI INTERACTIVE LABS ENDEAVORRX IS THE FIRST FDA APPROVED VIDEO GAME

A breakthrough ADHD pediatric treatment option

EndeavorRx has earned U.S. Food and Drug Administration (FDA) approval for the treatment of attention-deficit hyperactive treatment disorder (ADHD). It is the first FDA approved digital therapeutic software in the format of a video game that is available by prescription only. EndeavorRx was developed by Akili Interactive Labs.

EndeavorRx is indicated for pediatric patients ages 8 to 12 years old with primarily inattentive or combined-type ADHD who have demonstrated an attention issue. The approval is based on its ability to improve attention function as measured by computer-based testing and is the first digital therapeutic agent intended to improve symptoms associated with ADHD.  The product is designed for use as a component of a patient care program that may involve healthcare professional-directed therapy, medication, educational programs and other support that address symptoms of the disorder.

EndeavorRx has also been approved by European regulators through Conformite’ European (CE) Mark certification. 

Akili’s unique technology is at the center of EndeavorRx’s success

The creation of EndeavorRx was based on Akili’s Selective Stimulus Management Engine (SSME) proprietary technology. From the start, EndeavorRx was designed to focus and activate neural networks in the brain responsible for cognitive function. It delivers combined special sensory stimuli and motor challenges that center on activating neural systems associated with attention functions. It is also fortified with adaptive algorithms to customize the treatment experience based on each patient.

A technotherapeutic breakthrough

A video game therapeutic option to help treat ADHD (or any patient care issue for that matter!) will be welcomed by healthcare professionals and patients. It not only augments existing ADHD treatment options, it provides an interactive experience for patients to have a role in caring for themselves. 

Another important attribute in any prescribed therapy is patient adherence. EndeavorRx will be able to not only administer the treatment but also record patient interactions with the program to verify compliance and provide data-driven insights at to how the patient interacted with it. This will help parents and clinicians get a better idea of how well a patient is engaging the program. Data can also serve as building blocks to further enhance the product.

An important milestone reached by the FDA

The FDA continues to evolve as the healthcare industry continuously innovates. Every drug therapy, medical device and other products subject to FDA approval have their own nuances and complexities. By reviewing and approving EndeavorRx, the FDA achieves a breakthrough as a progressive organization that provides an objective evaluative forum dedicated to safety and efficacy that embraces entirely new approaches to advancing patient care.

Akili Interactive Labs has accomplished a remarkable achievement

Founded in 2011, Akili Interactive Labs is based in Boston, Massachusetts. EndeavorRx is the first product the company has launched that has earned FDA and CE regulatory approval. Akili has a distinguished and diverse lineup of organizations that are involved in its success. Some of its supporters and partners include Amgen, Autism Speaks, Canepa Healthcare (funding), Children’s Hospital of Philadelphia, Pfizer, PureTech Health (funding), San Francisco VA Medical Center, University of California San Francisco (UCSF) and University of Washington.