Northera droxidopa: Phase III data

Data from 147 evaluable NOH patients in the pre-specified modified intent-to-treat (mITT) population of the double-blind Phase III Study 306B trial in 174 NOH patients showed that Northera met the primary endpoint of improving the dizziness/light-headedness component of the OHSA scale at week 1 vs. placebo (placebo-adjusted improvement of 1 unit , p=0.018). Additionally, the proportion of patients who experienced a 2, 3 and 4 unit improvement on the endpoint at week 1 was significantly greater in the Northera arm vs. placebo (p<0.05 for all). Northera did not significantly improve the dizziness/light-headedness component of the OHSA scale vs. placebo at weeks 2, 4 or 8.

Northera also met the secondary endpoint of increasing standing SBP at week 1 vs. placebo (placebo-adjusted improvement of 5.6 mmHg, p=0.032). However, Northera did not significantly improve the rate of falls per week vs. placebo (0.4 vs. 2 falls/week). Northera also non-significantly improved the proportion of patients who experienced fall-related injuries, including contusions, lacerations and fractures, vs. placebo (16.9% vs. 25.6%). Preliminary safety data showed that Northera was well tolerated at all doses tested. The trial enrolled 174 patients, 27 of whom dropped out prior to week 1. Chelsea said it will conduct further analysis of the 306B data before deciding on next steps. ...