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From a Sept article      7-Nov-09 02:09 pm    
Here is part of an article published in Sept right after the disappointing 302 trial results. The longs should take comfort in 1. The safety comments. 2. The Japanese use. 3. The reduced numbers of falls seen in the 302 study patients treated with drox.

[Preliminary Safety Results

As anticipated, Droxidopa proved to be safe and well tolerated at all dose levels, with no significant adverse events or treatment related withdrawals in the Droxidopa arm.

The most common adverse events noted in the clinical trial were: supine hypertension at 12% for Droxidopa and 6% for placebo; falls at 2% for Droxidopa and 12% for placebo; and headache at 2% for Droxidopa and 8% for placebo.

"There is a long history of successfully treating neurogenic orthostatic hypotension with Droxidopa -- in the clinic, in the Japanese market, and here in the US through a long-standing compassionate use program," says Dr. Horacio Kaufmann, Professor of Neurology and Medicine at NYU School of Medicine, and investigator for this trial. "Having studied Droxidopa extensively, I firmly believe that this agent has a significant and clinically meaningful therapeutic benefit. I am looking forward to continuing to work with Chelsea to confirm these findings and bring Droxidopa to the US market. I have no doubts that patients suffering from symptomatic NOH in the US should have Droxidopa available."]
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hjertingii

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From a Sept article
hjertingii (2 Ratings) 7-Nov-09 02:09 pm  
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Chelsea Therapeutics International Ltd. (CHTP)

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