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Northera gets OK for Hypotension after 2nd look

FDA OKs Northera for Hypotension after 2nd look

Northera (droxidopa) has just been approved by the FDA (U.S. Food and Drug Administration).  It has been given a “thumbs up” for use in treating neurogenic orthostatic hypotension.  Neurogenic orthostatic hypotension is a rare disease that causes a patient’s blood pressure to drop when they stand.

It was turned down by the FDA two years ago because authorities wanted additional data and a second clinical trial.  Today’s official approval came following 2 two-week long clinical trials wherein patients on droxidopa said they experienced less lightheadedness, dizziness, faintness or a fear of blacking out than those who took a placebo.  Droxidopa (Northera) is reported to be “a pro-drug for norepinephrine” which as it crosses the blood-brain barrier serves as a vasoconstrictor which theoretically will aid users in retaining acceptable blood pressure even when they stand.

northera

Northera

The researchers did, however, suggest that the FDA should only approve Northera for short-term use since the research did not include any specifics regarding long-term use.  An FDA press release noted that Northera was approved under the FDA’s special “accelerated approval program” thus permitting Northera to be marketed for demonstrating its outcome on an “intermediate clinical measure” or, more specifically temporary respite from dizziness.

They also added in their communication that the “durability of the improvement in patient symptoms beyond two weeks has not been demonstrated.”  The Charlotte, North Carolina-based company Drugmaker Chelsea Therapeutics is charged with the job of conducting post-approval experiments to prove any long-term benefits regarding extended dizziness relief.

The FDA stated that it is important that clinicians remind patients who use Northera that they should sleep their heads and upper bodies raised.  They also noted that patients should have their supine blood pressure monitored both before and during treatment and more often as dosage is increased.  Therefore droxidopa (Northera) will include a boxed warning regarding the risk of increased blood pressure while lying down which is known to cause stroke.

Northera (droxidopa) is now available in 3different dosages including 100 mg, 200 mg, and 300 mg capsules.  Common side effects may include fatigue, headache, high blood pressure and nausea.

 (Image courtesy of MedPageToday)

FDA OKs Northera for Hypotension after 2nd look

About Will Phoenix

W. Scott Phoenix, B.A., B.S. was born in Hawaii, raised in Pennsylvania and resides in California. He has been a published writer since 1978. His work has appeared (under various names) in numerous places in print and online including Examiner.com. He is a single parent of three children and has also worked as an actor, singer and teacher. He has been employed by such publications as the Daily Collegian and the Los Angeles Times.

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