CHARLOTTE, N.C., March 19, 2013 (GLOBE NEWSWIRE) -- Chelsea Therapeutics International, Ltd. (Nasdaq:CHTP) today announced that Dr. Stuart Isaacson, Clinical Associate Professor, Department of Neurology, Herbert Wertheim College of Medicine, Florida International University, will present results from Northera™ (droxidopa) Study 306 at the American Academy of Neurology (AAN) 65th Annual Meeting which is taking place March 16-23, 2013 in San Diego. The presentation, titled "Droxidopa Treatment Impact on Orthostatic Symptoms and Standing Systolic Blood Pressure in Patients with Parkinson's Disease (PD) and Symptomatic Neurogenic Orthostatic Hypotension (NOH)," was accepted for dual presentation as part of the 2013 Emerging Science Program, and will be featured in a data blitz taking place on Wednesday, March 20 th, followed by a poster presentation. The data were also highlighted by AAN in a press release titled " New Drugs May Improve Quality of Life for People with Parkinson's Disease." "There remains a significant unmet need for new treatment options in NOH, an orphan disease which remains challenging to study," said Dr. Isaacson. "The empiric, data driven approach taken in studying droxidopa to date reveals a remarkably consistent, clinically meaningful effect across studies, as well as good tolerability. Study 306, in particular, highlights droxidopa's significant improvements on the symptoms of dizziness/lightheadedness and standing systolic blood pressure at 1 week, as well as important effects on falls and fall related injuries. These data suggest droxidopa is an important new therapy for patients living with Parkinson's disease and symptomatic NOH." The Company previously reported that based on results from Study 306B and Study 306 overall (Study 306A and Study 306B together), as well as recent guidance from the U.S. Food and Drug Administration, it intends to resubmit a Northera NDA in late second quarter 2013. Results Presented at AAN Results presented at AAN show that the hypotheses formed in Study 306A (n=51), including exploratory analyses regarding clinical trial parameters such as dizziness/lightheadedness (OHSA Item 1), rate of falls, and number of fall-related injuries, were confirmed in Study 306B (n=174).
Specifically, droxidopa was shown to improve both dizziness/lightheadedness (OHSA Item 1) and standing systolic BP at Week 1 (p=0.018 and p=0.032, respectively) in patients with NOH associated with PD compared with placebo. In addition, there was a lower rate of falls and fall-related injuries (e.g., contusions, lacerations, excoriations, and fractures) in patients who received droxidopa compared with placebo (not statistically significant). Data from the overall study (n=225) was consistent with that seen in Study 306B, including dizziness/lightheadedness (OHSA Item 1) at Week 1 (p=0.008) and Week 8 (p=0.077).Results also demonstrated that, although a large majority of patients were taking dopa-decarboxylase inhibitors, which are thought to potentially block the conversion of droxidopa to norepinephrine, their use did not appear to affect either the symptomatic effects of droxidopa or its effect on standing systolic blood pressure. Droxidopa was found to be safe and well tolerated (including no evidence of worsened PD), and the number and types of adverse events were consistent with previous studies. A copy of the poster presentation is available at www.chelsearx.com. About Northera NORTHERA™ (droxidopa), the lead investigational agent in Chelsea Therapeutics' pipeline, is currently in Phase III development for the treatment of symptomatic neurogenic orthostatic hypotension (NOH) in patients with primary autonomic failure — an indication that includes a significant number of patients with Parkinson's disease, multiple system atrophy (MSA) and pure autonomic failure (PAF). 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. About Chelsea Therapeutics Chelsea Therapeutics (Nasdaq:CHTP) is a biopharmaceutical development company that acquires and develops innovative products for the treatment of a variety of human diseases, including central nervous system disorders. Chelsea is currently pursuing FDA approval in the U.S. for Northera™ (droxidopa), a novel, late-stage, orally-active therapeutic agent for the treatment of symptomatic neurogenic orthostatic hypotension in patients with primary autonomic failure. For more information about the Company, visit www.chelseatherapeutics.com. This press release contains forward-looking statements regarding future events including our intention to pursue the development of Northera. These statements are subject to risks and uncertainties that could cause the actual events or results to differ materially. These include reliance on key personnel and our ability to attract and/or retain key personnel, the risk that FDA will not agree that our clinical trial results demonstrate the safety and effectiveness of droxidopa, the risk that the FDA will not accept our proposal regarding any trial or other data to support a new drug application; the risk that we will not be able to resubmit the NDA for Northera and that the FDA will not approve a resubmitted NDA; the risk that our resources will not be sufficient to conduct any study of Northera that will be acceptable to the FDA; the risk that we cannot complete any additional study for Northera without the need for additional capital; the risks and costs of drug development and that such development may take longer or be more expensive than anticipated; our need to raise additional operating capital in the future; our reliance on our lead drug candidate droxidopa; risk that we will not be able to obtain regulatory approvals of droxidopa or our other drug candidates for additional indications; risk of volatility in our stock price, related litigation, and analyst coverage of our stock; reliance on collaborations and licenses; intellectual property risks; our history of losses; competition; market acceptance for our products if any are approved for marketing.
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