Northera droxidopa: Phase II data
Top-line data from the double-blind, U.K. Phase II FMS201 trial in 120 patients showed that thrice-daily 600 mg oral droxidopa alone led to a 6.2 point improvement from baseline on the SF-MPQ at week 9, the primary endpoint, compared to a 3 point improvement for placebo. Additionally, droxidopa monotherapy led to greater reductions from baseline in mean VAS pain score (1.64 vs. 0.9 points) and mean FIQ score vs. placebo (9.72 vs. 4.74 points). Chelsea said that droxidopa as monotherapy was more effective than droxidopa plus carbidopa, but did not report results for the combination. No serious adverse events were reported with either droxidopa monotherapy or in combination with carbidopa. Chelsea said the trial was not powered to detect statistical significance. The amended 7-arm study is evaluating 600 mg oral droxidopa given 3 times daily; 50 mg carbidopa given 3 times daily; 400/25 mg, 200/50 mg, 400/50 mg or 600/50 mg of droxidopa/carbidopa given 3 times daily; or placebo. ...