This pooled analysis assessed the efficacy and safety of the
diclofenac epolamine topical patch 1.3% (
DETP) for the treatment of acute mild-to-moderate
ankle sprain. Data from 2 randomized, double-blind, placebo-controlled studies enrolling 274 male and female patients aged 18 to 65 years with acute
ankle sprain were pooled and evaluated. The primary end point was
pain reduction on movement assessed using a 100 mm visual analog scale (VAS). Safety and tolerability were also assessed. Beginning approximately 3 hours after initial treatment,
DETP-treated patients experienced statistically significant and sustained lower mean VAS scores in
pain intensity on movement (mean ± SD, 54.1 ± 20.0 mm versus 60.3 ± 16.8 mm) compared with placebo-treated patients, representing a 20% versus 13% reduction in VA S
pain scores from baseline (P = 0.012). This statistically significant difference in mean VAS score was maintained through day 7 (9.4 ± 14.4 mm versus 18.4 ± 18.2 mm, P < 0.0001). The
DETP and placebo patches were well tolerated. These results further confirm the efficacy and safety of
DETP for the treatment of
acute pain from
ankle sprains.