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Pregabalin has become the first drug to win approval by the Food and Drug Administration for the management of fibromyalgia.
The FDA based the approval on two double-blind, controlled trials of approximately 1,800 patients. Data from the studies have shown that patients with fibromyalgia "have decreased pain after taking [pregabalin], but, the mechanism by which [pregabalin] produces such an effect is unknown," according to an agency-issued statement.
In the clinical trials of patients with fibromyalgia, those on pregabalin (Lyrica) had "rapid and sustained improvements in pain," compared with those on placebo, and "reported feeling better and improvements in…
Source: HighBeam Research, Pregabalin is first drug approved for fibromyalgia.(Pain...