Lumos Labs has gained US Food and Drug Administration (FDA) clearance for LumosityRx, a prescription digital therapeutic (PDT) that aims to improve attention span in adult patients with attention deficit hyperactivity disorder (ADHD) at a time where incidence of the condition in the US is on the rise.
LumosityRx is indicated for patients aged between 22 and 55 with primarily inattentive or combined‐type ADHD. The PDT comes in the form of a mobile app that delivers clinically validated versions of 13 cognitive training games from Lumos Labs’ Lumosity brain training platform that target cognitive processes that contribute to attention function.
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A 2024 report by the US Centers for Disease Control and Prevention (CDC) deemed paediatric ADHD a “rising public health concern”. Using data from the 2022 National Survey of Children’s Health (NSCH), the research found that 7.1 million children and adolescents in the US received an ADHD diagnosis in 2022 – a million more of this demographic than in 2016.
Lumos highlighted that the PDT is positioned for use within broader therapeutic programmes to address ADHD that may also include therapy and medication to further address symptoms of the disorder, such as hyperactivity.
FDA clearance of LumosityRx was supported by Lumos’ pivotal trial (NCT05296473). The sham-controlled GAMES study enrolled more than 500 subjects in the US, finding that those who used LumosityRx demonstrated significant improvement of sustained and selective attention based on the TOVA Attention Comparison Score (ACS) test, versus those using a control app.
Clinicians who evaluated trial participants without knowing which treatment they received rated LumosityRx subjects as significantly more improved than control subjects on a global measure of clinical improvement (the CGI-I), with around one in three were rated as “much improved” or better.
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By GlobalDataDr Ann Childress, president of the Center for Psychiatry and Behavioral Medicine and principal investigator of the pivotal clinical trial, commented: “Adult ADHD is often misunderstood, and many patients still struggle to find treatment options that fit into their lives. Digital therapeutics like LumosityRx open up new possibilities.”
Lumos Labs is not the only company offering cognitive games as a treatment approach to ADHD. Last year, Akili’s EndeavorOTC became the first over-the-counter (OTC) ‘videogame’ to be approved by the agency for treating the disorder.
A report by GlobalData forecasts a steady increase in ADHD cases across the seven major markets (7MM; the US, Japan, Germany, France, the UK, Italy, and Spain) due to standardised screening tools and guidelines. The number of diagnosed prevalent cases of the disorder are expected to grow from 21.1 million in 2022 to 22 million by 2032.
