Axsome Therapeutics’ Phase III Focus trial investigating its attention-deficit hyperactivity disorder (ADHD) therapy, Sunosi (solriamfetol), has met its primary endpoint and provided a statistically significant 45% drop in ADHD symptoms.
The US-based company confirmed that the randomised, double-blind, placebo-controlled trial (NCT05972044) met both its primary and secondary endpoints, seeing mean reductions of 17.7 points for Sunosi 150mg and 14.3 points for placebo using the Adult ADHD Investigator Symptom Rating Scale (AISRS).
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Investigators defined a clinical response as a more than 30% improvement in baseline AISRS score, with that figure achieved by 53.5% of patients dosed with 150mg of Sunosi, compared with 41% in the placebo group.
Using the Clinical Global Impression of Severity (CGI-S) scale, researchers were similarly able to reduce overall ADHD severity compared with placebo.
The trial recruited 516 adults with ADHD who were randomised to receive either Sunosi 150mg, Sunosi 300mg, or a placebo, once-daily for six weeks. Patients in the 300mg group did see similar improvements to that of other cohorts but investigators ruled that results in this group were not statistically significant.
Gregory Mattingly, president of the American Professional Society for ADHD and Related Disorders, said: “ADHD substantially impairs social, academic, and occupational functioning while negatively impacting patient quality of life and increasing the risk of morbidity and mortality.
“The results of the Focus trial demonstrate that Sunosi was able to reduce mean ADHD symptom burden by nearly 50%, which contributed to significant reductions in disease severity. These results are especially promising as part of a comprehensive wellness plan for individuals with ADHD.”
Sunosi is currently available in the US as a therapy intended to treat excessive sleepiness related to narcolepsy and sleep apnoea. Research by GlobalData estimates that the therapy brought in $90m in the narcolepsy space alone last year. Analysis by GlobalData also estimates that across the major markets, the ADHD market is looking to decline from $11.9bn in 2022, down to $10.9bn in 2032.
GlobalData is the parent company of Clinical Trials Arena.
Elsewhere in treating ADHD, German device company Innosphere Engineering has started recruitment for the clinical trial for its device, Novostim 2.
