FDA Approves Rx for Neurogenic Orthostatic Hypotension
Northera (droxidopa) approved by FDA to treat neurogenic orthostatic hypotension
WEDNESDAY, Feb. 19, 2014 (HealthDay News) -- Northera (droxidopa) has been approved by the U.S. Food and Drug Administration to treat neurogenic orthostatic hypotension (NOH), a rare, chronic condition characterized by a sudden drop in blood pressure when a person stands.
NOH is most often associated with Parkinson's disease and other neurologic disorders.
Two clinical trials highlighted the effectiveness of Northera through two-weeks in people with NOH. Compared to patients taking a placebo, those taking Northera reported a decrease in lightheadedness, dizziness, feeling faint, or feeling as if they might black out. Patient symptom improvement has not been demonstrated beyond two weeks, according to the FDA.
Granted accelerated approval to treat a rare condition, the drug will have a boxed label warning that it could cause an unhealthy rise in blood pressure while a person is lying down. This potential side effect could lead to a stroke, the agency said, warning that Northera users should be monitored carefully.
Other less serious side effects could include headache, dizziness, nausea, high blood pressure, and fatigue, the FDA said.
Northera is produced by Chelsea Therapeutics, based in Charlotte, N.C.