FDA approves Pfizer's Lyrica for the treatment of the two most common forms of neurop...( NEW YORK December 31 2004 - Pfizer In...),Health

NEW YORK, December 31, 2004 - Pfizer Inc said today that it has received approval from the U.S. Food and Drug Administration (FDA) to market Lyrica^TM (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, which are distinctly different from arthritis or musculoskeletal pain.

Developed by Pfizer, Lyrica has a newly defined mechanism of action. 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 sustained pain relief," said Dr. Joseph Feczko, president of Worldwide Development at Pfizer. "Lyrica also represents a major achievement in Pfizer's research program and confirms our leadership in bringing life-changing medicines to patients."

Neuropathic pain, one of the most debilitating forms of pain, is caused by nerve damage that can result from underlying conditions, such as diabetes or shingles. Nearly half of the 18 million Americans with diabetes will develop some form of diabetic neuropathy over the course of their disease and about one in six diabetes patients will experience painful diabetic neuropathy. The pain of DPN is often described as burning, tingling, sharp, stabbing, or pins and needles in the feet, legs, hands or arms.

PHN is a complication of shingles, a painful outbreak of rash or blisters on the skin caused by a reactivation of the same virus that causes chicken pox. Each year, about 150,000 Americans develop PHN, which is often characterized as constant stabbing, burning, or electric shock-like sensation.

The efficacy of Lyrica was established in six double-blind, placebo-controlled trials, three involving patients with DPN and three involving patients with
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Contact: Rebecca Hamm
212-733-8811
Burson-Marsteller
7-Jan-2005

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