The
diclofenac epolamine topical patch 1.3% was designed to deliver
analgesic concentrations of
diclofenac to an underlying
soft tissue injury site, while limiting systemic exposure to
diclofenac. This randomized, double-blind, placebo-controlled study evaluated the safety and efficacy of the
diclofenac epolamine topical patch for the treatment of
acute pain due to minor
soft tissue injury. Patients (18-65 years, inclusive) with clinically significant minor
soft tissue injuries (mild or moderate
sprain, strain, or
contusion) incurred within 7 days of study entry and having
pain scores ≥ 5 on a Visual Analog Scale of 0-10 were enrolled. Patients were randomized to receive the
diclofenac epolamine topical patch (n=207) or placebo patch (n=211) application twice daily for 14 days or until
pain resolution. Patients recorded
pain scores every 12 h at the time of patch removal using the Visual Analog Scale. Investigator-assessed global response to
therapy was also evaluated. Safety data were collected throughout the study. Twice-daily treatment with
diclofenac epolamine topical patch produced a statistically significant reduction in mean
pain score relative to baseline by an additional 18.2% in the
diclofenac epolamine topical patch group (0.435 ± 0.268) compared with the placebo group (0.532 ± 0.293) (p=0.002; overall) beginning after application of the second patch. Consistent with this treatment effect, median time to
pain resolution was shortened by 2 days in the
diclofenac epolamine topical patch group relative to the placebo group (p=0.007). These results were reinforced independently by investigators who reported treatment as good or excellent for 58% of
diclofenac epolamine topical patch-treated patients compared with 49% in the placebo patch group (p=0.008). The most common adverse events were treatment site related (n=16, 7.9%
diclofenac epolamine topical patch; n=12, 5.8% placebo patch). Most (80%) patients reported tolerability as excellent or good. In conclusion, the
diclofenac epolamine topical patch provides effective, rapid
pain relief for the treatment of
acute pain from minor
soft tissue injury and appears generally safe and well tolerated.