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Chelsea Therapeutics Announces Presentation Of Northera(TM) (droxidopa) Study 306 Data At The American Academy Of Neurology Annual Meeting

Stocks in this article: CHTP

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 Northeraâ„¢ (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).

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