Droxidopa for symptomatic neurogenic orthostatic hypotension: what can we learn?

Excerpt

On February 18th 2014, the US Food and Drug Administration (FDA) approved droxidopa (Northera^®), an orally active synthetic precursor of norepinephrine, for the treatment of symptomatic neurogenic orthostatic hypotension (nOH). It was the first new drug approval for nOH in almost 20 years. Two years before, the FDA Cardiovascular and Renal Drugs Advisory Committee had voted 7 out of 13 in favor of approval, but the FDA requested more data. With the results of a new clinical trial, a second Committee meeting voted almost unanimously to approve droxidopa (16 in favor out of 17). Droxidopa was approved for the treatment of symptomatic nOH in patients with primary autonomic failure, a group of disorders that includes Parkinson disease (PD), pure autonomic failure (PAF), multiple system atrophy (MSA), dopamine beta-hydroxylase deficiency, and non-diabetic autonomic neuropathies. PD, MSA, and PAF are now classified as synucleinopathies, while non-diabetic autonomic neuropathy is a broad term that includes autoimmune, genetic, and other autonomic neuropathies. …