The U.S. Food and Drugs Administration approved Northera Capsules, a drug manufactured by Chelsea Therapeutics to treat a rare low blood pressure condition.
The go-ahead was given Feb.18 under the accelerated approval program. This program facilitates the approval of a drug to treat a serious health condition based on clinical data showing that the drug is effective on an intermediate clinical measure. The benefit of this program is that it gives patients access to promising drugs while the manufacturing company continues to conduct clinical trials post approval to verify the drug's clinical benefit.
The drug will be used to treat neurogenic orthostatic hypotension (NOH) - a rare, chronic and often debilitating drop in blood pressure on standing. The condition is associated with Parkinson's disease, multiple-system atrophy, and pure autonomic failure. Symptoms include dizziness, light-headedness, blurred vision, fatigue and fainting when a person stands.
"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 in a statement. "There are limited treatment options for people with NOH and we are committed to helping make safe and effective treatments available."
The capsules come with a boxed warning requesting health professionals to alert patients about the risk of increased blood pressure while lying down. Supine hypertension is a common problem among patients with primary autonomic failure and can cause stroke. The warning reminds such patients that they should sleep with their head and upper body elevated.
The side effects of Northera include headache, dizziness, nausea, high blood pressure (hypertension) and fatigue.
According to statistics, more than 100,000 patients in the U.S. currently suffer from neurogenic orthostatic hypotension. Current treatments for the disorder depend on the underlying cause of it. For mild orthostatic hypotension, one of the simplest treatments is to sit or lie down immediately after feeling lightheaded upon standing. Symptoms of orthostatic hypotension usually disappear. When low blood pressure is caused by medications, treatment usually involves changing the dose of the medication or stopping it entirely.
