FLECTOR Anti-Inflammatory Pain Relief Patch Available In US
Alpharma announced availability of FLECTOR Patch (diclofenac epolamine topical patch) 1.3%, the first and only anti-inflammatory pain relief patch in US. Available by prescription, the adhesive patch delivers medication directly to the site of pain, offering a safe and effective alternative to widely used nonsteroidal anti-inflammatory drugs (NSAIDs) that are taken orally. The targeted delivery of FLECTOR Patch through the skin results in minimal systemic absorption of diclofenac, one of the best selling and most widely used orally administered NSAIDs worldwide.
"The main drawback of commonly used oral anti-inflammatory medications is that many people cannot tolerate them," said Robert Sheu, M.D., Director of the Pain Division, Department of Pain Medicine and Palliative Care, Beth Israel Medical Center, New York. "There are a lot of physicians and patients who would prefer a more targeted approach to treating pain at the site of an injury, and a topical patch accomplishes this while avoiding the stomach and digestive tract." Studies have shown that up to 50 percent of patients who suffer from pain have intolerance to traditional oral NSAIDs.
Acute pain is a common problem with one in four Americans suffering an episode of pain lasting longer than 24 hours. FLECTOR Patch is indicated for the topical treatment of acute pain due to minor strains, sprains and contusions.
In a national survey released today by the National Pain Foundation (NPF), supported by a grant from Alpharma Pharmaceuticals LLC, 93 percent of survey respondents expressed that people take too many pills, and 82 percent said they would be interested in a prescription pain relief patch that delivers medication directly to the point of pain. Further reinforcing the need for new pain relief therapies, the survey shows that only 22 percent of people were very satisfied with the current method they used to treat their pain.
About FLECTOR Patch
Each FLECTOR Patch measures approximately 4 inches by 5.5 inches and contains 180 mg of diclofenac epolamine, which has demonstrated both anti-inflammatory and analgesic (pain-relieving) activities. The recommended dose of FLECTOR Patch is one patch to the most painful area twice a day (12 hours at a time). FLECTOR Patch should be applied to intact or non-damaged skin.
The prescribing information does not specify a limit on the duration of use for FLECTOR Patch; however, it should be used at the lowest effective dose for the shortest duration consistent with individual patient treatment goals.
FLECTOR Patch delivers significant pain relief with no serious adverse events observed in clinical trials for up to two weeks with approximately 600 patients. In addition, the incidence of gastrointestinal side effects such as nausea and upset stomach were comparable to placebo patch.
In the controlled trials, three percent of patients in both the FLECTOR Patch and placebo patch groups discontinued treatment due to an adverse event. The most common adverse events leading to discontinuation were application site reactions, occurring in two percent of both the FLECTOR Patch group and the placebo patch group.
Outside the U.S., the diclofenac patch has an extensive track record of safety, having been introduced in Switzerland in 1993, and is currently approved in 43 countries. No serious adverse events or fatalities have been reported, despite use in more than six million patients and totaling approximately 175 million patches.
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