Analgesic efficacy and safety of diclofenac epolamine topical patch (flector® patch) by location of injury in trials of acute pain: A pooled analysis of five trials

Objectives: To evaluate the efficacy and safety of the diclofenac epolamine topical patch (DETP) by injury location during short-term treatment of pain associated with minor sports injuries or inflammatory pathologies. Methods: The efficacy of the DETP was evaluated from the results of five clinical trials (three studies evaluated minor sports injuries and two evaluated inflammatory pathologies) based on injury location. Efficacy was summarized by treatment (the DETP or placebo) and by injury location into one of the following 10 categories: ankle, back, elbow, foot, arm/hand/wrist, knee, leg, neck, shoulder, and torso/other (abdomen, chest and side). Efficacy was analyzed by visual analog scale (VAS) scores for spontaneous pain, global response/efficacy evaluated by the patient and by the investigator. Safety was analyzed by tolerability analysis by both the patient and investigator, and adverse events (AEs) were recorded. Results: Patients treated with the DETP experienced a statistically significant improvement in VAS pain scores for the back, elbow, and shoulder compared to the placebo group. For the investigator assessment of global response/efficacy, there were statistically significant differences in patients treated with the DETP for the back, elbow, shoulder, and foot compared to patients treated with placebo. When tolerability was assessed by investigator, there was a statistically significant difference in tolerability in patients when the DETP was applied to the leg, compared to patients who received placebo. There were no differences in the types or numbers of AEs reported by both the DETP and placebo patients. Conclusions: The DETP demonstrated efficacy in reducing pain from acute injuries and has proven to be a safe, tolerable, and effective treatment for acute pain arising from injuries of the back, elbow, shoulder, and foot.