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

as given for only 24 percent of FLECTOR(R) Patch patients versus 34.4 percent of placebo patch patients (p<0.01).

Of the 418 patients randomized in the study, 49.3 percent were men and 99.5 percent were white. The mean age of the study participants was 38.9 years. The most common injuries reported were contusions (42.6 percent), strains (31.1 percent), and sprains (24.4 percent); the most common injury sites were ankle, shoulder, knee and foot (67.3 percent). Efficacy was evaluated in 384 (91.9 percent) patients (greater than or equal to one post- baseline pain assessment). Adverse events were similar between FLECTOR(R) Patch and placebo patch; the most common were application-site conditions, generally of mild severity (FLECTOR(R) Patch 7.9 percent, placebo patch 5.8 percent). The study was supported by a grant from Alpharma Pharmaceuticals LLC.

Comparison of Plasma Pharmacokinetics of FLECTOR(R) Patch and Oral Voltaren(R) in Healthy Volunteers (Abstract #8383/Poster #279)(3)

In order to compare the bioavailability of two formulations containing diclofenac, FLECTOR(R) Patch and Voltaren(R), a single-center, open-label, crossover study was conducted in 24 healthy volunteers. All study subjects received one FLECTOR(R) Patch every 12 hours for four consecutive days; 12 study subjects received a single 50-mg oral dose of Voltaren(R) in a two-way crossover fashion. Blood was collected at selected times post-dose to determine diclofenac plasma levels.

Results indicated that the systemic exposure to diclofenac with topical FLECTOR(R) Patch at a steady state (every 12 hours for four days) was approximately 1 percent of a single dose of Voltaren(R) (50-mg oral).

The study included an equal number of males and females, all Caucasian, with a mean age of 24.1 years. Subjects were required to have no skin disorders or abnormalities at the patch application site. Mean Cmax for FLECTOR(R) Patch (steady state) was 1.7 plus or minus 0.9ng/mL versu
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SOURCE Alpharma Inc.
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