Northera approved by FDA for symptomatic Neurogenic Orthostatic Hypotension - Chelsea Therapeutics

Chelsea Therapeutics International announced that the FDA has granted accelerated approval of Northera (droxidopa) for the treatment of symptomatic Neurogenic Orthostatic Hypotension (NOH). Northera is the first and only therapy approved by the FDA which demonstrates symptomatic benefit in patients with NOH. Northera is indicated for the treatment of orthostatic dizziness, lightheadedness, or the �feeling that you are about to black out� in adult patients with symptomatic NOH caused by primary autonomic failure (Parkinson�s disease, multiple system atrophy and pure autonomic failure), dopamine beta hydroxylase deficiency and non-diabetic autonomic neuropathy. The Northera approval was granted under the FDA�s accelerated approval program, which allows for conditional approval of a medicine that fills a serious unmet medical need, provided additional confirmatory studies are conducted.

The package insert indicates that effectiveness beyond 2 weeks of treatment has not yet been demonstrated, therefore the continued effectiveness of Northera in patients should be assessed periodically.