A Medical Device Daily

Alpharma (Bridgewater, New Jersey) reported positive results this week at this week's annual meeting of the American Pain Society (Glenview, Illinois) in Tampa, Florida, from two studies of Alpharma Pharmaceuticals' Flector Patch 1.3%, the first prescription anti-inflammatory pain relief patch in the U.S.

Flector Patch has been available in the U.S. since January for the topical treatment of acute pain due to minor strains, sprains and contusions.

Results of one study show that Flector Patch offered greater pain reduction and resolution of pain versus placebo patch. Results of another study demonstrate that the systemic exposure to drug in the patch, diclofenac, used every 12 hours over a period of four days was approximately 1% 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 Stauffer, DO, chief medical officer and senior vice president, clinical research and medical affairs for Alpharma Pharmaceuticals.

He added, "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."

In the first study, the efficacy and tolerability of Flector Patch was evaluated in a randomized, double-blind, placebo-controlled, parallel-group trial of 418 patients, ages 18-65, 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 used the patch every 12 hours on 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.

Patients treated with Flector Patch experienced improved mean pain scores (40.4% of baseline score) vs. patients using placebo patch (47.4%); overall pain reduction was 14.8%. Flector Patch patients also reached pain resolution three days sooner than those in the placebo patch group.

At the end of the study, the Investigator Global Assessment of Response to Therapy significantly favored the Flector Patch.

In the second study, which compared the patch to oral Voltaren, 24 healthy volunteers were included. All study subjects received one Flector Patch every 12 hours for four consecutive days; 12 study subjects received a single 50 mg oral dose of Voltaren in a two-way crossover fashion. Blood was collected at selected times post-dose to determine diclofenac plasma levels.

Results indicated that the systemic exposure to diclofenac with topical Flector Patch at a steady state (every 12 hours for four days) was approximately 1% of a single 50 mg dose of Voltaren.

Each Flector Patch measures about 4" by 5.5" and contains 180 mg of diclofenac epolamine, which has demonstrated both anti-inflammatory and analgesic activities and is generally used twice a day for12 hours at a time.