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June 19, 2014
16:38 EDTCHTPChelsea Therapeutics reports Phase 3 results of NORTHERA study
Chelsea Therapeutics announced the publication in Neurology of its pivotal, Phase 3 study 301, a multicenter, multinational, double-blind, randomized, placebo-controlled, parallel-group study of NORTHERA that details how NORTHERA demonstrated a statistically significant difference in efficacy compared to placebo for improving the symptoms of neurogenic orthostatic hypotension. NORTHERA was approved by the U.S. FDA on February 18, for the treatment of orthostatic dizziness, lightheadedness, or the "feeling that you are about to black out" in adult patients with symptomatic neurogenic orthostatic hypotension caused by primary autonomic failure (Parkinson's disease, multiple system atrophy, and pure autonomic failure), dopamine beta-hydroxylase deficiency, and non-diabetic autonomic neuropathy. Effectiveness beyond 2 weeks of treatment has not been demonstrated. The continued effectiveness of NORTHERA should be assessed periodically. Data from pivotal study 301, published online ahead of print in Neurology, was used to support the safety and efficacy of NORTHERA as part of its new drug application. The trial examined the efficacy and safety of droxidopa versus placebo. The primary endpoint was the relative improvement in mean Orthostatic Hypotension Questionnaire composite score following 1 week of treatment. The OHQ is a validated, NOH-specific tool assessing symptom severity and symptom impact on daily activities as reported by patients. When evaluating the OHQ composite, it was found that droxidopa-treated patients improved by 0.90 units (p=0.003), compared to placebo. Overall, this short-term multicenter trial showed that droxidopa treatment was associated with significant improvement in multiple symptoms of NOH and of NOH impact on activities requiring standing or walking as well as an associated increase in standing systolic BP. Furthermore, these benefits were associated with an acceptable safety profile.
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