Chelsea Therapeutics announced that the FDA has granted accelerated approval of Northera (droxidopa) for the treatment of symptomatic neurogenic orthostatic hypotension (NOH) caused by primary autonomic failure (eg, Parkinson’s disease, multiple system atrophy, pure autonomic failure), dopamine beta hydroxylase deficiency, and non-diabetic autonomic neuropathy.

Northera is the first FDA-approved drug to show symptomatic benefit in patients with NOH in nearly two decades.

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Northera, a synthetic amino acid analog, is believed to exert its pharmacological effects through norepinephrine and not through the parent molecule or other metabolites. Norepinephrine increases blood pressure by inducing peripheral arterial and venous vasoconstriction. The exact mechanism of action in the treatment of neurogenic orthostatic hypotension is unknown.

The clinical durability of Northera is set to be established in a multi-center, placebo-controlled, randomized study, which includes a 4-week randomized withdrawal phase preceded by a 3-month open label run-in phase. The trial would include approximately 1,400 patients who may be enrolled over a six year period in agreement with the FDA.

Northera will be available as 100mg, 200mg, and 300mg capsules in 90-count bottles in the second half of 2014.

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