Akili, Inc, a leading digital medicine company, announced topline results of the STARS-ADHD-Adult clinical trial evaluating the efficacy and safety of EndeavorRx in adults with attention-deficit/hyperactivity disorder (ADHD). STARS-ADHD-Adult was designed as a pivotal clinical trial to enable registration with the U.S. Food and Drug Administration (FDA). The trial demonstrated statistically significant improvement in attention functioning after six weeks of treatment, achieving its predefined primary efficacy outcome.
Significant improvements were also seen across a range of secondary and exploratory outcomes, including clinical assessments of ADHD-related symptoms and a validated measure of quality of life. EndeavorRx treatment was well-tolerated, with minimal side effects and no serious device-related adverse events reported. Millions of American adults are diagnosed with ADHD, and recent reports suggest that rates have risen in recent years. This is magnified by the substantial challenges this large group of patients face in accessing effective treatment.
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EndeavorRx is currently authorized by the FDA for the treatment of inattention in children ages 8-12 with ADHD, and in January Akili announced topline data from a successful pivotal study of EndeavorRx in adolescents with ADHD ages 13-17. For both objective measures of attention and clinical outcomes, the improvements observed in adults surpassed those in both the pediatric and adolescent patient populations.
“Not only did the benefit of EndeavorRx in adults with ADHD exceed what we’ve seen in kids and adolescents, adults using the treatment experienced meaningful improvements in their quality of life,” said Scott Kollins, Ph.D., chief medical officer of Akili. “These data come at a critical time when there is growing demand among adults with ADHD for safe, effective, and accessible non-drug treatments. It is increasingly recognized that current available options are not working, and/or are not available. We are deeply committed to getting this treatment to patients as quickly as possible. We are evaluating regulatory strategies and look forward to sharing more soon.”
The multi-center open-label study enrolled 221 adults, 18 years of age and older, with inattentive or combined-type ADHD. Patients used the video game-based digital treatment on a mobile device in their homes for six weeks. In the study, EndeavorRx demonstrated a statistically significant improvement in the Test of Variables of Attention -Attention Comparison Score (ACS) of sustained and selective attention from baseline after six weeks of treatment (p<0.0001), the study’s predefined primary efficacy outcome.
SOURCE: Businesswire