Lumos Labs has obtained a clearance from the FDA for its popular Lumosity brain training platform, greenlighting a version of it to be marketed as a prescription digital therapeutic for adults with attention-deficit/hyperactivity disorder (ADHD) for the first time.
Dubbed LumosityRx, the agency’s 510(k) covers the smartphone app’s use in improving attention among people between the ages of 22 and 55. According to Lumos, more than 100 million people have already used its Lumosity platform, and the FDA’s clearance marks the company’s expansion from consumer software to clinical-grade approaches.
It’s also a major turnaround from 2016, when the company came under the ire of the Federal Trade Commission (FTC) for false product claims related to its brain training programs and their potential to stave off age-related cognitive decline, dementia and the effects of Alzheimer’s disease. The FTC fined Lumos $50 million, though the company settled for a payment of $2 million.
“With LumosityRx, we’re taking the core science and technology behind Lumosity and applying it to help people with ADHD, where attention is crucial to everyday life,” Bob Schafer, head of Lumos’ digital medicine division, said in a statement.
Initially developed under the name Prismira, LumosityRx includes versions of 13 Lumosity cognitive training games designed to exercise the cognitive processes that back broader attention function.
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In a clinical trial that included more than 500 participants across the U.S., LumosityRx demonstrated “significantly greater” gains in objective measures of sustained and selective attention, as well as impulse control and response consistency, that are used to help diagnose ADHD and other attention disorders in children and adults.
In the study, 44.2% of participants that used LumosityRx showed clinically meaningful gains in attention stats, the company said.
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“Adult ADHD is often misunderstood, and many patients still struggle to find treatment options that fit into their lives,” said principal investigator Ann Childress, M.D., president of the Center for Psychiatry and Behavioral Medicine. “Digital therapeutics like LumosityRx open up new possibilities: clinically validated, highly engaging, and accessible from a mobile device.”
In other fields, the FDA issued a clearance this past April to Click Therapeutics’ app as the first prescription digital therapeutic to help prevent migraines, in coordination with drug therapies. And, this year, Click, through a collaboration with the drugmaker Boehringer Ingelheim, also saw its app for schizophrenia clear a phase 3 trial.
