The U.S. Food and Drug Administration has given green signal to Chelsea Therapeutics ‘s new drug Northera that helps in treating a rare low blood pressure disorder.
Northera capsules (droxidopa) got approval from the federal agency early this week. The drug helps in treating a rare form of low blood pressure disorder called neurogenic orthostatic hypotension (NOH).
Neurogenic orthostatic hypotension is a condition when the person suffering from the disease feels low blood pressure upon standing. It is caused by the malfunction of the autonomic nervous system (ANS) that are responsible for controlling involuntary activity. The common symptoms of this form of disorder are dizziness, blurred vision, fatigues, fainting and lightheadedness when a person stands.
People suffering from neurological diseases like Parkinson’s, pure autonomic failure, multiple system atrophy (MSA), diabetic neuropathy and others are at higher risk of suffering this rare blood pressure disorder.
“People with neurogenic orthostatic hypotension are often severely limited in their ability to perform routine daily activities that require walking or standing. There are limited treatment options for people with NOH and we are committed to helping make safe and effective treatments available,” 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 the FDA, the common side effects of the drug include headache, nausea, high blood pressure, fatigue and dizziness.
The drug was given go ahead under the ‘accelerated approval program’ of the FDA. The program permits the approval of a drug to treat serious diseases based on present clinical data that highlights the effect of the novel drug on an intermediate clinical measure. This gives access to the drug as the company carries on further clinical trials.
