June 12, 2014
Chelsea Therapeutics Presents Efficacy and Safety Data for NORTHERA at International Congress of Parkinson's Disease and Movement Disorders
-First Presentation of Integrated Data Analyses From Two Pivotal Trials
-Data Shows Statistically Significant Improvement in Symptoms of NOH vs. Placebo
CHARLOTTE, N.C. and STOCKHOLM, Sweden, June 12, 2014 (GLOBE NEWSWIRE) -- Chelsea Therapeutics International, Ltd. (Nasdaq:CHTP) today announced the presentation of an integrated analysis of data from two pivotal multicenter, placebo-controlled, randomized clinical trials showing that NORTHERA™ (droxidopa) had demonstrated an acceptable safety profile and demonstrated a statistically significant difference in efficacy compared to placebo for improving the symptoms of neurogenic orthostatic hypotension (NOH) in a population comprised chiefly of patients with Parkinson's Disease (PD). The results were presented at the 18th International Congress of Parkinson's Disease and Movement Disorders (MDS) in Stockholm, Sweden, June 8-12, 2014.
NORTHERA was approved by the U.S. Food and Drug Administration on Feb. 18, 2014, 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. Symptomatic NOH is an orphan condition that affects an estimated 80,000 to 150,000 patients in the United States. As part of its New Drug Application, Chelsea submitted data from pivotal studies 301 and 306 in support of the safety and efficacy of NORTHERA. For MDS, data from these studies were integrated, analyzed and presented together, marking the first time these data were presented at a major medical meeting. MDS draws more than 4,000 physicians and medical professionals from more than 80 countries to view more than 1,600 scientific abstracts submitted by clinicians from around the world.
The posters, titled Integrated Efficacy of Droxidopa for Neurogenic Orthostatic Hypotension and Integrated Safety of Droxidopa for Neurogenic Orthostatic Hypotension, were presented at the Parkinson's disease dysautonomia Poster Session at MDS.
"Overall, 359 patients contributed data to the integrated efficacy analyses, 174 randomized to droxidopa and 185 to placebo. Patients on NORTHERA self-reported more improvements in NOH symptoms of dizziness/lightheadedness, feeling faint or the 'feeling that you are going to black out' compared to patients on placebo," said Robert A. Hauser, MD, Professor of Neurology, Molecular Pharmacology, and Physiology, and Director of the Parkinson's Disease and Movement Disorders Center, University of South Florida. "Patients on NORTHERA also showed improvements in standing systolic blood pressure at one week compared to patients on placebo."
Dr. Hauser was the lead author on the integrated efficacy poster.
Horacio Kaufmann, MD, Professor of Neurology and Medicine at New York University and Director of the Dysautonomia Center at NYU Langone Medical Center, was the lead author on the safety poster. "Droxidopa demonstrated an acceptable safety profile across these two pivotal induction design trials in patients in NOH, and data shows that adverse events were consistent across studies 301 and 306 and consistent with other studies of droxidopa," he said.