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FDA Approves Drug for Treatment of Neuropathic Pain March 2005 Pfizer to Market Lyrica Pfizer Inc. announced that it has approval from the U.S. Food and Drug Administration (FDA) to market Lyrica (pregabalin capsules) for the management of neuropathic pain associated with diabetic peripheral neuropathy (DPN) and postherpetic neuralgia (PHN). Lyrica is the first FDA-approved treatment for both of these neuropathic pain states. Lyrica will be available to physicians and patients in the near future. "Lyrica is an important new therapy for millions of people suffering from the two most common neuropathic pain conditions as it provides rapid and susttained pain relief," said Dr. Joseph Feczko, president of Worldwide Development at Pfizer. The efficacy of Lyrica was established in six double-blind, placebo-controlled trials, three involving patients with DPN and three involving patients with PHN. Lyrica provided rapid and clinically meaningful pain reduction in a significant portion of patients, with pain relief beginning as early as the first week of treatment in some patients. Pain relief was sustained in studies of up to 12-weeks duration. The safety of Lyrica was established in over 9,000 patients. In all clinical trials, adverse events were mild to moderate. The most common side effects associated with Lyrica compared with placebo included dizziness, somnolence, dry mouth, peripheral edema, blurred vision, weight gain and difficulty with concentration/attention. The discontinuation rate due to side effects was low. |
