March 31, 2005

Study Compares Lidoderm Patch and Celebrex for Osteoarthritis Pain

Endo Pharmaceuticals has released clinical trial data that found patients receiving either Lidoderm or Celebrex 200 mg for pain associated with osteoarthritis (OA) of the knee experienced improvement in average daily pain intensity.

Lidoderm (lidocaine patch 5 percent) is a topical analgesic patch approved by the FDA in 1999 to treat the pain associated with postherpetic neuralgia, a chronic condition resulting from nerve damage caused by shingles.

Because of safety concerns regarding the entire Cox-2 inhibitor class in the fall of 2004, Endo Pharmaceuticals has 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, 54 percent experienced a 30 percent or greater improvement in average daily pain intensity; (studies have reported that 30 percent or greater reductions in pain intensity are clinically meaningful to pain patients). In the Celebrex (celecoxib) group, 62 percent experienced a 30 percent or greater improvement in average daily pain intensity. In addition, clinically meaningful reductions in pain were noted in both treatment groups at Week 12.

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 because of adverse events. There were no discontinuations because of treatment-related adverse events in the Celebrex group.

Source: FDA News