Chelsea Therapeutics announced positive preliminary results for Study 306B, a Phase 3 trial evaluating the safety and efficacy of the investigational drug Northera (droxidopa) for the treatment of symptomatic neurogenic orthostatic hypotension associated with Parkinson’s Disease. Droxidopa is a synthetic catecholamine that is directly converted to norepinephrine (NE) via decarboxylation, resulting in increased levels of NE in the nervous system, both centrally and peripherally.
Results showed that treatment with Northera provided clinically meaningful and statistically significant improvements compared to placebo in dizziness/lightheadedness at Week 1 (1 unit change; P=0.018), the primary endpoint. In addition, compared to placebo, a statistically significantly greater number of patients were observed to experience 2, 3 or 4 unit improvements at Week 1 compared to baseline (all P-values<0.05). Study results also demonstrated a statistically significant increase in standing systolic blood pressure (SBP) at Week 1 (5.6mmHg; P=0.032), a key secondary endpoint of the study. At time points beyond Week 1, dizziness/lightheadedness and standing blood pressure predominantly favored Northera-treated patients.
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