FLECTOR Patch Yields Significantly Reduce Pain
Alpharma's two studies demonstrate the efficacy, tolerability and positive pharmacokinetic profile of Alpharma Pharmaceuticals' FLECTOR Patch (diclofenac epolamine topical patch) 1.3%, the first and only prescription anti-inflammatory pain relief patch in the United States. FLECTOR Patch has been available since January in the United States for the topical treatment of acute pain due to minor strains, sprains and contusions.
Results of one study, to be presented Friday, May 9, show that FLECTOR Patch offered greater pain reduction and resolution of pain versus placebo patch. Results of another study, to be presented Thursday, May 8, demonstrate that the systemic exposure to diclofenac, or amount of active drug circulating in the bloodstream, with FLECTOR Patch used topically every 12 hours over a period of four days was approximately 1 percent of a single 50-mg oral dose of the non-steroidal anti-inflammatory drug (NSAID) Voltaren (diclofenac sodium enteric-coated tablets).
"Many physicians and patients would prefer a targeted approach to treating pain at the site of an injury, for a number of reasons," said Joseph W. Stauffer, D.O., Chief Medical Officer, Senior Vice President, Clinical Research and Medical Affairs, Alpharma Pharmaceuticals. "In addition to supporting the effectiveness of FLECTOR Patch in reducing pain, these data confirm that the targeted delivery of FLECTOR Patch results in minimal systemic absorption of diclofenac, one of the best selling and most widely used orally administered NSAIDs worldwide."
Acute pain is a common problem, with one in four adult Americans suffering an episode of pain lasting longer than 24 hours.
Efficacy and Tolerability of FLECTOR Patch in the Treatment of Minor Soft Tissue Injury Pain
The efficacy and tolerability of FLECTOR Patch was evaluated in a randomized, double-blind, placebo-controlled, parallel-group trial of 418 patients, aged 18-65 years who rated the minor soft tissue injuries they sustained within seven days of study entry as having a pain intensity of greater than or equal to five on a zero to 10 scale. Patients self-administered FLECTOR Patch every 12 hours to the injury site. The primary study outcome was post-treatment pain, expressed as a proportion of the baseline pain score, which was recorded on a visual analog scale of zero to 10 in a diary, twice-daily for 14 days, or until pain resolution. The secondary study outcomes included end-of-treatment Investigator Global Assessment of Response to Therapy (a five-point scale, "none" to "excellent"), and time to pain resolution (four scores less than or equal to two).
Patients treated with FLECTOR Patch experienced improved mean pain scores (40.4 percent of baseline score) versus patients using placebo patch (47.4 percent, p<0.05); overall pain reduction was 14.8 percent. FLECTOR Patch patients also reached pain resolution three days sooner than those in the placebo patch group (median, 10.0 versus 13.5 days, p=0.01). Additionally, at the conclusion of the study, the Investigator Global Assessment of Response to Therapy significantly favored the FLECTOR Patch: patient response to treatment was rated "good" to "excellent" for 57.8 percent of FLECTOR Patch patients, versus 48.4 percent of placebo patch patients, and a "no"/"poor" response was given for only 24 percent of FLECTOR Patch patients versus 34.4 percent of placebo patch patients (p<0.01).
Of the 418 patients randomized in the study, 49.3 percent were men and 99.5 percent were white. The mean age of the study participants was 38.9 years. The most common injuries reported were contusions (42.6 percent), strains (31.1 percent), and sprains (24.4 percent); the most common injury sites were ankle, shoulder, knee and foot (67.3 percent). Efficacy was evaluated in 384 (91.9 percent) patients (greater than or equal to one post- baseline pain assessment). Adverse events were similar between FLECTOR Patch and placebo patch; the most common were application-site conditions, generally of mild severity (FLECTOR Patch 7.9 percent, placebo patch 5.8 percent). The study was supported by a grant from Alpharma Pharmaceuticals LLC.