Chelsea Therapeutics Announces New Data from Northera Phase III Program in Neurogenic Orthostatic Hypotension

Chelsea Therapeutics International, Ltd. CHTP announced that new data from Phase III trials in symptomatic neurogenic orthostatic hypotension demonstrating the activity and tolerability of NORTHERA™ (droxidopa), an orally active synthetic precursor of norepinephrine, were presented at the Movement Disorder Society's 15^th International Congress of Parkinson's Disease and Movement Disorders in Toronto, Ontario, Canada. In addition to the two posters presentations, Chelsea sponsored a symposium detailing the clinical results of Northera for the treatment of neurogenic orthostatic hypotension and reviewing the role of norepinephrine depletion in the pathophysiology of Parkinson's disease and autonomic failure. Copies of both posters and the presentations from the symposium are available on the Chelsea website at www.chelseatherapeutics.com. In a poster, "Safety and efficacy of Northera in Multiple System Atrophy," (Abstract Number: 778), Gregor K. Wenning, MD, PhD MSc, Medical University, Innsbruck, Austria, highlighted the results of a meta-analysis of Northera Studies 301 and 302 showing the mean Orthostatic Hypotension Questionnaire composite score of Northera-treated patients improved significantly (2.9 units; P<0.05) from baseline to study completion when compared to placebo-treated patients (1.7 units). Greater improvement in standing systolic blood pressure, mean composite Orthostatic Hypotension Symptom Assessment, and Orthostatic Hypotension Daily Activity Scale scores of the Northera- vs. placebo-treated patients was also observed. These findings were consistent with the results of the full study population in Study 301, presented by Dr. Wenning during the symposium, in which Northera-treated patients demonstrated improvements in multiple signs and symptoms of NOH including a statistically significant (p=0.003) improvement in OHQ Composite score, statistically significant benefit in 8 out of 10 individual OHQ items and a significant improvement (p ≤ 0.001) in standing SBP compared to placebo. "The results from our clinical trials in neurogenic orthostatic hypotension have consistently highlighted the broad symptomatic benefits of Northera in patients with autonomic failure and we are delighted to have had these findings showcased at the Movement Disorder Society's annual meeting," commented Dr. Art Hewitt, Chelsea's Chief Scientific Officer. "These most recent data from Study 306A, though preliminary, suggests that in addition to chronic symptoms such as dizziness, weakness and fatigue, patients with NOH associated with Parkinson's disease are at a high risk for falls and associated injuries. If our on-going trial, Study 306B, replicates these early findings, it could not only have significant implications for the future treatment of neurogenic orthostatic hypotension but could also have important implications for subsequent studies in Parkinson's disease and other movement disorders associated with norepinephrine depletion. "