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Data Show FLECTOR(R) Patch Yields Significant Pain Reduction for Acute Strains, Sprains and Contusions
Date:5/8/2008

s Voltaren(R) (single dose), 1214 plus or minus 750ng/mL. Area under the plasma concentration curve (AUC) for zero to 12 hours was FLECTOR(R) Patch at 15.2 plus or minus 6.9ng*h/mL versus Voltaren(R), 1754 plus or minus 1060 ng*h/mL. The dose-adjusted relative percent bioavailability of diclofenac after treatment with FLECTOR(R) Patch versus Voltaren(R) was 0.7 plus or minus 0.4 (i.e., <1 percent). The study was supported by a grant from Alpharma Pharmaceuticals LLC.

About FLECTOR(R) Patch

Each FLECTOR(R) Patch measures approximately 4 inches by 5.5 inches and contains 180-mg of diclofenac epolamine, which has demonstrated both anti-inflammatory and analgesic (pain-relieving) activities. The recommended dose of FLECTOR(R) Patch is one patch to the most painful area twice a day (12 hours at a time). FLECTOR(R) Patch should be applied to intact or non-damaged skin.

Although the prescribing information does not specify a limit on the duration of use for FLECTOR(R) Patch, it recommends that FLECTOR(R) Patch be used at the lowest effective dose for the shortest duration consistent with individual patient treatment goals.

FLECTOR(R) Patch delivers significant pain relief with rates of common adverse events with FLECTOR(R) Patch similar to placebo patch observed in clinical trials for up to two weeks with approximately 600 patients. In addition, the incidence of gastrointestinal side effects such as nausea and upset stomach were comparable to placebo patch.

In the clinical trials, 3 percent of patients in both the FLECTOR(R) Patch and placebo patch groups discontinued treatment due to an adverse event. The most common adverse events leading to discontinuation were application site reactions, occurring in 2 percent of both the FLECTOR(R) Patch group and the placebo patch group.

Outside the U.S., the diclofenac patch has an extensive track record of safety, having been introduced in Switzerland in 1993, and is currently approved in 4
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SOURCE Alpharma Inc.
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