Replies to post #150 on Chelsea Therapeutics Intl Ltd fka CHIP

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UPDATE 1-Chelsea Therapeutics hypotension drug meets trial goal

Mon Sep 20, 2010 7:29am EDT

* Says drug improved symptoms related to low blood pressure

* Drug was safe and well tolerated

* Shares up 58 pct in premarket trade

Sept 20 (Reuters) - Chelsea Therapeutics International Ltd (CHTP.O) said a late-stage study of its hypotension drug met the main goal of improving the symptoms related to low blood pressure compared to a dummy drug, sending its shares up 58 percent.

The study, which was conducted under a special protocol assessment granted by U.S. health regulators, also showed that the drug Northera, also called droxidopa, was both safe and well tolerated at all dose levels.

Patients on the trial were tested for symptomatic and functional improvement using a questionnaire designed to rate the severity of symptoms resulting from low blood pressure and the degree those symptoms interfere with a patient's ability to perform daily activities.

Neurogenic orthostatic hypotension, a chronic and often debilitating drop in blood pressure upon standing, affects over 100,000 patients in the United States, the company said.

It is a disorder of the nervous system, characterized by low blood pressure, lightheadedness, dizziness, blurred vision and fainting episodes upon standing.

Additionally, Northera also showed a statistically significant improvement in standing systolic blood pressure compared to the dummy drug.

Headache was the most common adverse event reported, with all cases considered mild, the company said in a statement.

Last September, the drug had failed in a late-stage trial as it could not show statistically significant improvement over a dummy drug. [ID:nBNG340801]

The company's shares were up 58 percent $8 in premarket trade. They closed at $5.06 Friday on Nasdaq. (Reporting by Esha Dey in Bangalore)