FDA Approves Northera Capsules to Treat Rare Low Blood Pressure Disorder

The U.S. Food and Drug Administration gives the go ahead to Chelsea Therapeutics 's new drug Northera to treat a rare low blood pressure disorder.

Early this week, the federal agency approved Northera capsules (droxidopa) to treat a rare form of low blood pressure disorder called neurogenic orthostatic hypotension (NOH). The disorder  causes dizziness, blurred vision, fatigues, fainting and lightheadedness when a person stands. Those with neurological diseases like Parkinson's disease , pure autonomic failure, diabetic neuropathy and multiple system atrophy (MSA), generally suffer from it.

"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. "There are limited treatment options for people with NOH and we are committed to helping make safe and effective treatments available."

Neurogenic orthostatic hypotension is defined as low blood pressure upon standing. It is basically caused by the malfunction of the autonomic nervous system (ANS) responsible for controlling involuntary activity. Noh is a sub type of orthostatic hypotension (OH).

The federal agency okayed the drug under the 'accelerated approval program' that 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 .

The newly approved Northera capsules carry a boxed warning about risk of increased blood pressure while lying down. This disorder referred to as supine hypertension is a common disorder that affects people with primary autonomic failure and also causes stroke. It is therefore, necessary to monitor supine blood pressure before and during the treatment also when the doses increase.

On taking this drug, it is essential that the patient sleeps with their head and upper body elevated.

The common side effects noticed during the clinical trial are headache, nausea, high blood pressure, fatigue and dizziness.The drug has also received the orphan-product designation by the federal agency as it is meant to treat a rare disease or condition.