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Solriamfetol Significantly Reduces ADHD Symptoms in Axsome’s Phase 3 Trial
Axsome’s phase 3 trial shows solriamfetol significantly improves ADHD symptoms, with a 45% mean reduction in AISRS scores and onset as early as week 1.
Axsome Therapeutics announced on March 25, 2025, that the FOCUS Phase 3 trial achieved its primary endpoint, with solriamfetol significantly improving ADHD symptoms compared to placebo.
More than that, the pivotal study demonstrated that solfriamfetol had an onset of action as early as week 1.
“The results of the FOCUS trial demonstrate that solriamfetol was able to reduce mean ADHD symptom burden by nearly fifty percent, which contributed to significant reductions in disease severity,” said Gregory Mattingly, MD, associate clinical professor of psychiatry at the Washington University School of Medicine, in a statement. “These results are especially promising as part of a comprehensive wellness plan for individuals with ADHD.”
ADHD, characterized by a persistent pattern of inattention, hyperactivity, or impulsivity, interferes with functioning or development, hindering attention, planning, problem-solving, working memory, and behavioral inhibition. In the US, approximately 15.5 million adults have ADHD, and this psychiatric disorder is linked to an estimated total annual societal excess cost of > $120 billion. Among the approximate 7 million children with ADHD, about two-thirds continue to experience symptoms into adulthood.
FOCUS, a randomized, placebo-controlled, multicenter trial, sought to evaluate the efficacy and safety of solriamfetol in US adults with ADHD. Solriamfetol is a dopamine and norepinephrine reuptake inhibitor, TAAR1 agonist, and 5-HT1A angonist currently being developed to treat ADHD, major depressive disorder, binge eating disorder, and excessive sleepiness associated with shift work disorder.
Investigators randomized 515 adults with ADHD 1:1:1 to receive a once-day solriamfetol 150 mg, solfriamfetol 300 mg, or placebo for 6 weeks. The primary endpoint was the change from baseline in adult ADHD Investigator Symptom Rating Scale (AISRS) total score (range: 0 – 54) at week 6. The greater the score, the greater the symptom severity. The secondary endpoint was the change from baseline in the Clinical Global Impression of Severity (CGI-S) for ADHD at week 6.
Participants had mean baseline AISRS total scores of 39.1 for solriamfetol 150 mg, 38.3 for solriamfetol 300 mg, and 37.9 for placebo. The phase 3 trial showed participants on solriamfetol had a 45% mean reduction from baseline in the AISRS total score compared to placebo. Participants on solriamfetol 150 mg had a mean reduction of 17.7 points, compared with a reduction of 14.3 points among those on placebo (P = .039).
The trial observed improvements in the AISRS total score with solriamfetol as early as week 1 compared with placebo (P = .036).
Clinical response, defined as ≥ 30% improvement from baseline in the AISRS total score, was achieved by a significantly greater percentage of patients treated with solriamfetol 150 mg (53.5%) compared with placebo (41.3%) at week 6 (P = .024).
Moreover, FOCUS achieved its key secondary endpoints, significantly reducing overall ADHD disease severity compared to placebo, as assessed by the Clinical Global Impression of Severity (CGI-S) for ADHD (P = .017).
As for the findings on the primary and secondary endpoints for the 300 mg dose of solriamfetol, the change from baseline in the AISRS total score and CGI-S score was numerically superior to placebo but not statistically significant.
“The symptom improvements observed with solriamfetol were accompanied by a favorable safety and tolerability profile,” Mattingly continued. “Based on these compelling data, solriamfetol has the potential to be an important new treatment option for adult patients living with ADHD.”
Axsome Therapeutics plans to initiate a trial on solriamfetol for pediatric patients this year.
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