Efficacy and tolerability of FLECTOR® Patch (diclofenac epolamine topical patch) in the treatment of minor soft tissue injury pain

FLECTOR^® Patch (diclofenac epolamine topical patch) was recently approved in the US for treatment of acute pain due to minor strains, sprains, and contusions. This randomized, double-blind, placebo-controlled, parallel-group trial evaluated efficacy and tolerability of FLECTOR^® Patch, self-administered every 12h to injury site, in patients aged 18-65y with minor soft tissue injury within 7d of study-entry and pain intensity ≥5 (0-10 scale). Primary outcome: post-treatment pain, expressed as proportion of baseline pain score, which had been recorded on a visual analog scale (0-10) in the diary twice-daily for 14d or until pain resolution. Secondary outcomes included end-of-treatment Investigator Global Assessment of Response to Therapy (5-point scale, none-excellent) and time to pain resolution (4 scores ≤2). Of 418 patients randomized, 49.3% were men, 99.5% were white; mean age was 38.9y. Most common injuries were contusion (42.6%), strain (31.1%), and sprain (24.4%); most common sites were ankle, shoulder, knee, and foot (67.3%). Efficacy was evaluated in 384 (91.9%) patients (≥1 post-baseline pain assessment). Patients treated with FLECTOR^® Patch experienced improved mean pain scores (40.4% of baseline score) vs patients using placebo (47.4%, p<0.05); overall pain reduction, 14.8%. Patients treated with FLECTOR^® Patch reached pain resolution 3-days sooner than those in the placebo group (median, 10.0 vs 13.5 days, p=0.01). At study end, Investigator Global Assessment of Response to Therapy significantly favored FLECTOR^® Patch; patient response to treatment was rated good-excellent for 57.8% FLECTOR^® Patch vs 48.4% placebo and no/poor response for 24.0% FLECTOR^® Patch vs 34.4% placebo (p<0.01). Adverse events were similar between treatments; most common were application-site conditions, generally of mild severity (FLECTOR^® Patch, 7.9%; placebo, 5.8%). FLECTOR^® Patch yielded significant pain reduction for injuries due to strain, sprain, and contusion.

Supported by a grant from Alpharma Pharmaceuticals LLC.