FDA Okays Chelsea's Blood Pressure Drug Northera

Chelsea Therapeutics' Northera capsule (droxidopa) is now approved for the treatment of neurogenic orthostatic hypotension (NOH), The U.S. Food and Drug Administration said Tuesday.

This is the first product by North Carolina-based Chelsea to hit the market, Bloomberg reported.

Neurogenic orthostatic hypotension is a rare disorder where the blood pressure falls abruptly when standing up. It is caused by autonomic nervous system (ANS) malfunction.. The condition occurs in people with Parkinson's disease, multiple-system atrophy, or pure autonomic failure.

"People with neurogenic orthostatic hypotension are often severely limited in their ability to perform routine daily activities that require walking or standing," said Norman Stockbridge, M.D., Ph.D, director of the Division of Cardiovascular and Renal Drugs in the FDA's Center for Drug Evaluation and Research, according to a statement by FDA.

The efficacy of the drug was tested via a two-week clinical trial where people with NOH were given either Northera or a placebo. Researchers found that people on the test drug reported a decrease in symptoms when compared with those taking the placebo. Researchers aren't sure if the efficacy of the drug lasts more than two weeks.

The drug has been approved under the accelerated approval program and Chelsea will have to conduct post-marketing studies to find the efficacy of the drug in treating the disease in people with long-term NOH, FDA said.

Northera will need to carry a boxed warning that informs healthcare practitioners about the risk of increase in blood pressure while lying down- a condition known as supine hypertension.

Robyn Karnauskas, an analyst with Deutsche Bank AG, said Feb. 14 that treatment for NOH will generate about $450 million in peak U.S. sales, Bloomberg reported.

 "The approval of NORTHERA is an extraordinary achievement, one for which I thank patients and their families, investigators and the medical community, our partner Dainippon Sumitomo, and our employees," said Joseph G. Oliveto, President and Chief Executive Officer of Chelsea Therapeutics, according to a statement released by the company.

Side effects of using the drug include dizziness, headache, nausea, fatigue and high blood pressure.

The FDA announcement helped Chelsea Therapeutics' shares rise by 35 percent to $6.70 during post-session trade, MarketWatch reported.