Pfizer’s Lyrica gains fibromyalgia indication
Executive Summary
Pfizer gains FDA approval June 21 for Lyrica (pregabalin) as the first drug for the management of fibromyalgia. Pfizer's sNDA was supported with a four-week double-blind, controlled clinical trial and a six-month randomized withdrawal study involving about 1,800 patients. While many patients taking Lyrica in studies experienced decreased pain, FDA cautions that results did not occur in all participants. Label for Lyrica recommends fibromyalgia patients receive doses of 300 mg to 450 mg per day. Lyrica, a Schedule V drug, was already approved for the management of postherpetic neuralgia and neuropathic pain associated with diabetic peripheral neuropathy, indications FDA cleared in December 2004 (1"The Pink Sheet" Jan. 10, 2005, p. 5)...
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