The U.S. Food and Drug Administration (FDA) recently approved Northera (droxidopa) for treatment of neurogenic orthostatic hypotension, a rare disease that causes a patient's blood pressure to drop when they stand.
Two years ago, the FDA gave the drug a thumbs down, saying they needed additional data and a second clinical trial. To reach today's official approval, a pair of two-week clinical trials was conducted to observe patients taking droxidopa and those taking a placebo.
Those on the drug said they experienced less lightheadedness, dizziness, faintness or fear of blacking out compared to the placebo group. Droxidopa is reportedly "a pro-drug for norepinephrine," which is a vasoconstrictor as it crosses the blood-brain barrier, and can theoretically aid patients in maintaining a normal blood pressure when they stand.
Because no trials testing long-term use of the drug have been carried out, researchers recommend that the FDA only approve droxidopa for short-term use. In the mean time, the company, Drugmaker Chelsea Therapeutics in Charlotte, N.C., will be piloting post-approval experiments to determine any long-term benefits.
Droxidopa was approved under their "accelerated approval program," allowing it to be marketed as a temporary relief from dizziness.
One expert notes that this condition can be limiting to those who suffer from it, and that providing treatment options is a priority.
"There are limited treatment options for people with NOH and we are committed to helping make safe and effective treatments available," Dr. Norman Stockbridge, director of the Division of Cardiovascular and Renal Drugs in the FDA's Center for Drug Evaluation and Research, said in an FDA press release.
The FDA noted that it is important that clinicians inform patients using droxidopa that they should sleep with their heads and upper bodies raised, and that they should have their supine blood pressure monitored both before and during treatment, and more often as dosage is increased. The drug will carry a warning label about the risk of increased blood pressure while lying down, which is known to cause stroke.
Droxidopa now comes in three different dosages: 100 mg, 200 mg, and 300 mg capsules. Its common side effects may include fatigue, headache, high blood pressure and nausea.
