Chelsea also intends to initiate a new clinical trial in the fourth quarter of 2013, given guidance regarding the potential need for Chelsea to verify the durability of effect of Northera in a post-marketing study. This study would also include short-term clinical endpoints should the Agency require an additional clinical trial for the approval of Northera.Chelsea recently reported that Study 306B demonstrated statistically significant improvements for Northera compared to placebo in dizziness/lightheadedness at week 1 (p=0.018), the primary endpoint, and increase in standing systolic blood pressure at week 1 (p=0.032), an important secondary endpoint. Treatment with Northera also resulted in a reduction in patient falls and fall-related injuries, also secondary endpoints, although the results were not significant. The safety data were consistent with previous studies, and showed that Northera was well tolerated.
Chelsea Therapeutics Receives FDA Guidance For A Northera(TM) (Droxidopa) NDA Resubmission With Study 306B
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