FDA approves Northera for hypotension
FDA Approves Rx for Neurogenic Orthostatic Hypotension
HealthDay News -- The FDA has approved Northera (droxidopa) to treat neurogenic orthostatic hypotension, a rare chronic condition characterized by a sudden drop in blood pressure when a person stands.
Neurogenic orthostatic hypotension is most often associated with Parkinson's disease and other neurologic disorders.
The drug's approval was based on results from two two-week clinical trials in which patients on droxidopa reported less dizziness, lightheadedness, feeling faint or feeling as if they might black out during the study period than those on placebo.
Patient symptom improvement has not been demonstrated beyond two weeks, according to the FDA. The drug was granted accelerated approval, which enables products to go on-market after demonstrating an effect on an "intermediate clinical measure" -- in this case, short-term dizziness relief.
Droxidopa will carry a boxed label warning about the risk for an unhealthy rise in BP while a person is lying down. This potential side effect could lead to a stroke, the agency said, warning that users should be monitored carefully.
The FDA is urging clinicians to remind patients to sleep with their head and upper body elevated, and that supine BP needs to be monitored before and during treatment, and more frequently when increasing doses. The drug is available in 100 mg, 200 mg and 300 mg capsules.
Other less serious side effects include headache, dizziness, nausea, hypertension and fatigue, the FDA said.
Northera is produced by Chelsea Therapeutics, based in Charlotte, N.C.