RESEARCH - First Study to Compare Lidoderm Patch and Celebrex in Treating Pain Associated With OA of the Knee

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Via Joan A.:

First Head-To-Head Study to Compare Lidoderm Patch and Celebrex in

Treating Pain Associated With Osteoarthritis of the Knee

Study Results Suggest That Lidoderm Can Alleviate the Pain Associated

With Osteoarthritis of the Knee

CHADDS FORD, Pa., March 31 /PRNewswire-FirstCall/ -- 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 meaningful reductions in pain were noted

in both treatment groups at week 12.

" Although these results need to be confirmed with further randomized

controlled trials, the potential of Lidoderm to treat osteoarthritis knee

pain is promising, " added Dr. Kivitz. " Lidoderm has been used since 1999 to

treat the pain of post-herpetic neuralgia and, because it is a non-systemic

patch, has demonstrated a minimal risk of side effects or drug-to-drug

interaction. Our hope is to see similar results in further Lidoderm

osteoarthritis knee pain studies. "

About the Study

The randomized, open-label, active-control, parallel-group study,

which was intended to enroll 200 patients, contained data for 143 patients

experiencing OA pain of either one or both knees and evaluated efficacy and

safety of treatment. After a 7- to 14-day wash-out period during which all

analgesic medications, chondroitin, and glucosamine were discontinued,

patients with an average daily pain intensity score of greater-than or

equal-to 5 on a scale of 0 to 10 for three of five consecutive days and an

OA severity score of greater-than or equal-to 7 on a scale of 0 to 24 prior

to the baseline visit were randomized to 12 weeks of treatment with either

one full Lidoderm patch on the front of the knee and one-third of a patch on

the back of each affected knee (69 patients) once daily for 24 hours or

Celebrex 200 mg once daily (74 patients). Efficacy measures included the

Western Ontario and McMaster Universities OA Index, Brief Pain Index (BPI),

Pain Quality Assessment Scale and global assessments of change in OA pain

and treatment satisfaction.

In the study, both treatments were well tolerated, with adverse events

reported in eight patients in each group. The most common adverse events

were itchiness or redness at the patch site. Additionally, three patients in

the Lidoderm group discontinued the study due to adverse events. There were

no discontinuations due to treatment-related adverse events in the Celebrex

group.

About Lidoderm

Lidoderm (lidocaine patch 5%) is FDA-approved for the relief of pain

associated with post herpetic neuralgia (PHN). Lidoderm produces an

analgesic effect by the penetration of lidocaine from the patch into the

epidermal and dermal layers of the skin, without loss of sensation or

numbness. The Lidoderm patch should only be applied to intact skin. The most

frequently reported adverse events with the Lidoderm patch are application

site reactions, including erythema, edema, discoloration, burning sensation,

pruritus or abnormal sensation. These reactions are generally mild and

transient, resolving spontaneously within a few minutes to hours.

The FDA-approved dosing for Lidoderm is up to three patches applied

for up to 12 hours within a 24-hour period. Lidoderm has not been approved

by the FDA for any indications other than for the relief of pain associated

with PHN, and its safety and efficacy in other indications have not been

established.

About Endo

A wholly owned subsidiary of Endo Pharmaceuticals Holdings Inc.

(Nasdaq: ENDP), Endo Pharmaceuticals is a fully integrated specialty

pharmaceutical company with market leadership in pain management products.

The company researches, develops, produces and markets a broad product

offering of branded and generic pharmaceuticals, meeting the needs of

healthcare professionals and consumers alike. More information, including

this and past press releases of Endo Pharmaceuticals Holdings Inc., is

available online at http://www.endo.com.

Celebrex® is a registered trademark of Pfizer Inc.

Forward-Looking Statements

This press release contains forward-looking statements, within the

meaning of Section 27A of the Securities Act of 1933 and Section 21E of the

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of the factors that will determine the Company's future results are beyond

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subject to risks and uncertainties and, therefore, actual results may differ

materially from those expressed or implied by these forward-looking

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SOURCE Endo Pharmaceuticals Inc.

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