Axsome Therapeutics (AXSM) said Tuesday that the phase 3 trial of solriamfetol as a potential treatment for attention deficit hyperactivity disorder achieved its primary and key secondary endpoints, demonstrating "statistically significant" improvement in symptoms and disease severity.
The study met its primary endpoint of a statistically significant reduction in the Adult ADHD Investigator Symptom Rating Scale compared with placebo at week six. The study also achieved the key secondary endpoint of a significant reduction in overall ADHD disease severity, Axsome added.
Solriamfetol was also well-tolerated in the study, with no serious adverse events reported, according to Axsome.
Axsome Chief Executive Officer Herriot Tabuteau said the company plans to start a solriamfetol trial in pediatric patients this year.
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