Axsome released phase 3 clinical data from the (FOCUS) study with drug Solriamfetol for Attention Deficit Hyperactivity Disorder (ADHD), with results being statistically significant, rated under the AISRS (primary endpoint) versus placebo with 150mg dose.
FOCUS Phase 3 Results:
- AISRS compared to placebo p=0.039
- CGI-S compared to placebo p=0.017
The company will next have to run a pediatric phase 3 study scheduled for 2025. If positive then can submit to the FDA a new drug application. The advantage over current treatments, is that Solriamfetol is considered a non-stimulant drug, and potential improvement from a safety profile from currently approved ADHD drugs on the market. Thank you for reading.
No comments:
Post a Comment