Chelsea Therapeutics Announces Results From Northera(TM) (droxidopa) Study in Spinal Cord Injury at the 23rd …

CHARLOTTE, N.C., Nov. 6, 2012 (GLOBE NEWSWIRE) -- Chelsea Therapeutics International, Ltd. (CHTP) today announced results from a study of Northera(TM) (droxidopa) in hypotensive individuals with spinal cord injury at the 23rd International Symposium on the Autonomic Nervous System, which took place October 31 through November 3, 2012 in Paradise Island, Bahamas.

The poster, titled "Blood Pressure Effect of Droxidopa in Hypotensive Individuals with Spinal Cord Injury," (poster #62) highlighted results of a clinical study designed to determine the blood pressure effect of escalating doses of droxidopa (100 mg, 200 mg & 400 mg) during three laboratory visits in hypotensive subjects (n=10) with spinal cord injury (SCI). The level of SCI ranged from cervical to low thoracic lesions, all were chronically injured and non-ambulatory and 8 were motor complete.

Subjects were hypotensive at baseline (systolic BP: 87+/-14 mmHg; diastolic BP: 54+/-8 mmHg), and baseline BP did not differ among the 3 visits. Upon supine repositioning prior to drug administration, BP increased significantly (SBP: 101+/-11 mmHg; DBP: 62+/-7 mmHg; p<0.0001 versus seated baseline), regardless of dose, droxidopa did not augment the increase in BP upon supine repositioning. Seated BP was significantly increased from baseline after droxidopa in a dose-dependent manner (100 mg: 94+/-14/61+/-8 mmHg; 200 mg: 99+/-15/62+/-9 mmHg; 400 mg: 106+/-16/58+/-9 mmHg; p<0.0001). Although the elevation in seated BP was relatively modest, average 4-hour seated SBP & DBP were significantly increased with 400 mg droxidopa compared to 100 mg (p<0.001) and 200 mg (p<0.05).

"These preliminary data indicate that droxidopa increases seated BP in a dose-dependent manner without worsening supine increases in BP in hypotensive persons with SCI, suggesting a greater normalization of pressure across positional changes," said lead author Jill M. Wecht, Ed.D, Associate Professor of Medicine and Rehabilitation Medicine, the Mount Sinai School of Medicine. "Increasing seated blood pressure is an important clinical outcome in these individuals, because hypotension has been linked to deficits in memory and attention processing in the general population and in individuals with SCI. Further study of droxidopa is warranted in the SCI population."

About Northera

NORTHERA(TM) (droxidopa), the lead investigational agent in Chelsea Therapeutics' pipeline, is currently in Phase III clinical trials for the treatment of symptomatic neurogenic orthostatic hypotension (NOH) in patients with primary autonomic failure -- a group of diseases that includes 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 (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(TM) (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 http://www.chelseatherapeutics.com.

This press release contains forward-looking statements regarding future events. These statements are subject to risks and uncertainties that could cause the actual events or results to differ materially. These include the risk that the FDA will not accept any proposal regarding any trial or other data to support Study 301 or any other study, including the primary endpoint; 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 develop 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 of regulatory approvals of droxidopa or our other drug candidates for additional indications; reliance on collaborations and licenses; intellectual property risks; our history of losses; competition; and market acceptance for our products if any are approved for marketing.

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Chelsea Therapeutics Announces Results From Northera(TM) (droxidopa) Study in Spinal Cord Injury at the 23rd ...