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FDA Approves Northera (Droxidopa) for Patients With Neurogenic Orthostatic Hypotension
The FDA has approved Northera (droxidopa, Chelsea Therapeutics) for the treatment of neurogenic orthostatic hypotension (NOH).
NOH is a rare, chronic, and often debilitating drop in blood pressure upon standing that is associated with Parkinson's disease, multiple-system atrophy, and pure autonomic failure. Symptoms of NOH include dizziness, lightheadedness, blurred vision, fatigue, and fainting when a person stands.
The labeling for Northera includes a boxed warning to alert health care professionals and patients about the risk of supine hypertension, a common problem that affects people with primary autonomic failure and that can cause stroke.
The most common adverse events associated with droxidopa in clinical trials were headache, dizziness, nausea, hypertension, and fatigue.
The effectiveness of droxidopa was shown through 2 weeks in two clinical studies in subjects with NOH. Subjects taking droxidopa reported a decrease in dizziness, lightheadedness, feeling faint, or feeling as if they might black out compared with those taking placebo. The durability of the improvement in patient symptoms beyond 2 weeks has not been demonstrated.
Source: FDA; February 18, 2014.