Research Brief
Chelsea Therapeutics International says it's completed a Phase II trial of droxidopa for fibromyalgia, and that the results were favorable.
Droxidopa is a man-made precursor of the neurotransmitter norepinephrine, which is believed to be deficient in people with fibromyalgia. Droxidopa currently is approved in Japan for orthostatic hypotension (OH) resulting from several conditions. OH causes a drop in blood pressure when standing, which can result in dizziness, fainting, weakness and other symptoms. OH is common in fibromyalgia; however, in this study researchers looked at how effective droxidopa is against pain.
As research moves forward, the company says it will focus on a combination of droxidopa and a drug called carbidopa, which allows droxidopa to cross the blood-brain barrier. So far, researchers say they're seeing the most pain reduction by using multiple daily doses of this combination. They also report no safety concerns.
Droxidopa currently is not approved for use outside of Asia, but it's currently in clinical trials in the U.S., Canada, Europe and Australia. Some Phase III trials are now underway, meaning it could come on the market within the next couple of years.
Droxidopa has only a few reported side effects that are generally mild. They include rapid heart beat, high blood pressure, nausea and vomiting, and headache/migraine.
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