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news.Pfizer has reported that the FDA has approved its Lyrica capsules for the management of fibromyalgia, one of the most common chronic, widespread pain conditions in the US.
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The company claims that Lyrica’s approval, which received a priority review, represents a breakthrough for the more than six million Americans who suffer from this debilitating condition who previously had no FDA approved treatment options.
Pfizer undertook a clinical development program to evaluate Lyrica’s effectiveness. The drug Lyrica demonstrated rapid and sustained improvements in pain compared with placebo. In addition, patients taking Lyrica reported feeling better and improvements in physical function.
Lyrica has been prescribed to more than five million patients worldwide, and had about $1.2 billion in global sales last year.
In addition to this new indication in the US, Lyrica is approved for the management of neuropathic pain associated with diabetic peripheral neuropathy and post-herpetic neuralgia, and for the adjunctive therapy for adult patients with partial onset seizures.