Diclofenac epolamine topical patch relieves pain associated with ankle sprain

Abstract

David R Lionberger1, Eric Joussellin2, Arturo Lanzarotti3, Jillmarie Yanchick4, Merrell Magelli5 1Southwest Orthopedic Group, LLP, Houston, Texas, USA; 2Institut National du Sport, Paris, France; 3Institut Biochimique SA, Pambionoranco, Switzerland; 4Alpharma Pharmaceuticals LLC, a wholly owned subsidiary of King Pharmaceuticals®, Inc, Piscataway, New Jersey, USA; 5GTx, Inc, Memphis, Tennessee, USABackground: Sports-related injuries, such as sprains and strains, commonly occur during exercise and athletic events. Current therapy includes nonsteroidal anti-inflammatory drugs (NSAIDs), which have a high incidence of upper gastrointestinal side effects. The present study assessed the efficacy and safety of the diclofenac epolamine topical patch (DETP, 1.3%), a topical NSAID for the treatment of acute minor sprains and strains.Methods: This multicenter, randomized, placebo-controlled clinical study enrolled adult patients (n = 134) with acute ankle pain (due to a minor sprain) occurring less than 48 hours prior to entering the study. Patients were treated with either the DETP or a placebo topical patch daily for seven days. Pain intensity was evaluated during the first six hours after application of the patch, and on treatment days 1, 2, 3, and 7.Results: Patients treated with the DETP experienced a significantly greater reduction in pain associated with their ankle injury compared with placebo, beginning four hours after the first patch application (P = 0.02). The DETP was well tolerated and was comparable with placebo in terms of safety.Conclusion: Overall, the results of this study demonstrate that the DETP is an effective analgesic for local treatment of pain in mild acute ankle sprain.Keywords: soft tissue injury, acute pain, visual analog scale, efficacy, tolerability