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First head-to-head study to compare lidoderm patch and Celebrex in treating pain

CHADDS FORD, Pa., March 31, 2005 Today at the 24th Annual Scientific Meeting of the American Pain Society, Endo Pharmaceuticals Inc. released new clinical trial data which found patients receiving either Lidoderm (lidocaine patch 5%) or Celebrex (celecoxib) 200 mg for pain associated with osteoarthritis (OA) of the knee experienced improvement in average daily pain intensity. Lidoderm is a topical analgesic patch approved by the U.S. Food and Drug Administration (FDA) in 1999 to treat the pain associated with post-herpetic neuralgia (PHN), a chronic condition resulting from nerve damage caused by shingles.

"The results of this exploratory study examining Lidoderm and Celebrex suggest that Lidoderm can alleviate the pain associated with osteoarthritis of the knee," said Alan Kivitz, M.D., of Altoona (Pa.) Center for Clinical Research. "I am encouraged by these findings since there is a critical need for new approaches to managing this type of pain."

OA affects more than 20 million Americans annually and generates more than seven million physician visits per year. If left untreated, chronic pain conditions such as OA can have significant physical, psychological and financial consequences by affecting daily functioning and quality of life.

Due to safety concerns regarding the entire COX-II inhibitor class in the fall of 2004, the sponsor of the study, Endo Pharmaceuticals Inc., voluntarily elected to prematurely halt the study prior to reaching the original enrollment target. However an analysis of data after six weeks of treatment showed that of the patients treated in the Lidoderm group (N=56), 54% experienced a 30% or greater improvement in average daily pain intensity; (studies have reported that 30% or greater reductions in pain intensity are clinically meaningful to pain patients). In the Celebrex group (N=63), 62% experienced a 30% or greater improvement in average daily pain intensity. In addition, clinically meaningfu
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Contact: Fiona Buraimoh
fiona_buraimoh@nyc.cohnwolfe.com
212-798-9512
Cohn & Wolfe
31-Mar-2005


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