Lumos Labs, creators of the popular Lumosity brain training platform with over 100 million users, announced today that the U.S. Food and Drug Administration (FDA) has granted 510(k) clearance for LumosityRx, a prescription digital therapeutic (PDT) designed to improve attention in adults with Attention Deficit Hyperactivity Disorder (ADHD), ages 22 to 55.
A Clinically Validated Option for Adult ADHD
ADHD persists into adulthood for millions, impacting careers, relationships, and mental well-being. LumosityRx provides a new, engaging, and evidence-based alternative for improving attention function. LumosityRx is used as part of a therapeutic program that may include clinician directed therapy, medication, and/or educational programs, which further address symptoms of the disorder, such as hyperactivity.
LumosityRx is a new mobile app that delivers clinically validated versions of 13 Lumosity cognitive training games targeting cognitive processes that contribute to attention function.
“Adult ADHD is often misunderstood, and many patients still struggle to find treatment options that fit into their lives,” said Dr. Ann Childress, President of the Center for Psychiatry and Behavioral Medicine, Inc., and Principal Investigator of the pivotal clinical trial. “Digital therapeutics like LumosityRx open up new possibilities: clinically validated, highly engaging, and accessible from a mobile device.”
Strong Evidence from a Rigorous Clinical Trial
LumosityRx was evaluated in the GAMES Study, a randomized, double-blind, sham-controlled clinical trial that included more than 500 participants across 13 U.S. clinical sites. Participants using LumosityRx showed significantly greater improvement on an objective measure of sustained and selective attention (the TOVA test) compared to those using a control app. Results of the primary endpoint analysis showed that the improvement in the TOVA Attention Comparison Score (ACS) with use of the therapeutic module of the app was statistically significantly larger than in the control arm (p=0.0149).
With the new FDA clearance, the company is now working toward a product launch that supports seamless access nationwide.
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