Chelsea Therapeutics and Droxidopa

Chelsea Therapeutics will seek federal approval for its blood pressure drug.
Northera is designed to treat neurogenic orthostatic hypotension, which is a drop in blood pressure. The product is Chelsea's lead drug candidate and the company does not yet have a product on the market.
Chelsea Therapeutics International Ltd. has previously said it hopes to launch the drug in early 2012. Meanwhile, the company will continue to study the drug as a potential treatment for neurogenic orthostatic hypotension from Parkinson's Disease.
The active ingredient in Northera is droxidopa and Chelsea is also studying droxidopa as a treatment for fibromyalgia, a chronic disease that causes muscle pain and fatigue.
http://www.businessweek.com/ap/financialnews/D9MM7E2G0.htm

Droxidopa, Northera, and Chelsea Therapeutics

CHARLOTTE, N.C. (AP) - Chelsea Therapeutics International Ltd. reported a wider fourth-quarter loss Wednesday as it continued development of its hypotension drug candidate Northera.
Chelsea Therapeutics does not have any products on the market, and it did not report any revenue. The company is preparing to file for Food and Drug Administration approval of Northera, and hopes to launch the drug in early 2012.
Northera is designed to treat neurogenic orthostatic hypotension, which is a drop in blood pressure on standing. The FDA plans to conduct an expedited six-month review of the company's marketing application, and if the drug is approved, it will receive extended market exclusivity.
Chelsea Therapeutics said its research and development costs climbed to $10.2 million from $4 million. It said development of Northera, along with initial manufacturing and validation of the active ingredient in the drug, and a mid-stage trial of a rheumatoid arthritis drug were the causes of the increase in spending.
The active ingredient in Northera is droxidopa. Chelsea Therapeutics is also studying droxidopa as a treatment for fibromyalgia, a chronic disease that causes muscle pain and fatigue.
http://www.canadianbusiness.com/markets/market_news/article.jsp?content=D9LNCBS80

Chelsea Therapeutics: Northera (droxidopa)

About Northera™
Northera (droxidopa), the lead investigational agent in Chelsea Therapeutics' broad 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. Droxidopa is also being studied for the treatment of fibromyalgia, adult attention deficit disorder and chronic fatigue syndrome in three ongoing Phase II trials and completed a Phase II study in intradialytic hypotension (IDH) study with positive results.
http://www.globenewswire.com/newsroom/news.html?d=209503