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Published on 11/16/2005 in the Prospect News Biotech Daily.

Endo says Celebrex, Lidoderm research shows both drugs significantly improve chronic low back pain

By E. Janene Geiss

Philadelphia, Nov. 16 - Endo Pharmaceuticals Inc. said Wednesday that new data from an open-label clinical study evaluating Lidoderm and the COX-2 inhibitor Celebrex showed that patients with chronic low back pain experienced 30% or greater improvement in average daily pain intensity.

Due to safety concerns in the fall of 2004 regarding the entire COX-2 inhibitor class of drugs, study sponsor Endo voluntarily halted the study prior to reaching the original enrollment target of 200 patients, officials said in a company news release.

But a post-hoc analysis of the data on 97 patients after four weeks of treatment showed that 36.1% of the patients in the Lidoderm group saw clinically meaningful improvement in daily pain intensity, and 26.3% of patients in the Celebrex group experienced about the same level of improvement.

Results also showed that 75.8% of Lidoderm patients were satisfied with their treatment while 72.2% of Celebrex patients were satisfied. At four weeks, both groups reported experiencing improved quality of life, including general activity, sleep, mood and walking ability, officials said.

"There is a critical need for new options for treating patients with chronic low back pain," Bruce Nicholson of Penn State University School of Medicine and director of the Division of Pain Medicine at Lehigh Valley Hospital, said in the release. "Although [the] results need to be confirmed in larger, double-blind, placebo-controlled studies, I am encouraged by these findings."

Low back pain, a common painful condition, affects about two-thirds of adults at some time during their lives. If left untreated, low back pain can cause unnecessary suffering and negatively affect a person's life at home and on the job, Nicholson added.

Results of the study were presented Wednesday at the American College of Rheumatology's annual scientific meeting in San Diego.

Lidoderm, a lidocaine patch, is registered trademark of Hind Healthcare Inc. Celebrex is a registered trademark of Pfizer Inc.

Endo is a Chadds Ford, Pa.-based specialty pharmaceutical company.


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