Chelsea Therapeutics asks FDA to approve Northera

Wed, 09/28/2011 - 8:45am
The Associated Press

Chelsea Therapeutics International Ltd. said Wednesday it asked the Food and Drug administration to approve its drug Northera, which is designed to help prevent falling in patients with conditions like Parkinson's disease.

Chelsea Therapeutics said it asked the FDA to conduct a faster review of Northera. If the FDA grants that request, it would make a decision in six months instead of the usual 10, and make a ruling on Northera in late March. Northera, or droxidopa, is designed to treat neurogenic orthostatic hypotension, which is a drop in blood pressure on standing. It's a common symptom of Parkinson's disease, and can make patients get dizzy and fall.

In June, the company said a clinical trial showed patients treated with Northera were less likely to fall and hurt themselves.

Shares of Chelsea Therapeutics fell 8 cents, or 2.1 percent, to $3.90.


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