BRIDGEWATER, N.J., Jan. 23 /PRNewswire-FirstCall/ -- Alpharma Inc. , a global specialty pharmaceutical company, announced today the availability of FLECTOR(R) Patch (diclofenac epolamine topical patch) 1.3%, the first and only anti-inflammatory pain relief patch in the United States. 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(R) Patch through the skin results in minimal systemic absorption of diclofenac, one of the best selling and most widely used orally administered NSAIDs worldwide.
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“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(1).
Acute pain is a common problem with one in four Americans suffering an episode of pain lasting longer than 24 hours(2). FLECTOR(R) 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(3).
About FLECTOR(R) Patch
Each FLECTOR(R) 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(R) Patch is one patch to the most painful area twice a day (12 hours at a time). FLECTOR(R) 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(R) Patch; however, it should be used at the lowest effective dose for the shortest duration consistent with individual patient treatment goals.
FLECTOR(R) 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(R) 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(R) 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.
Contraindications and Safety Information
NSAIDs may cause an increase risk of serious cardiovascular thrombotic events, myocardial infarction, and stroke which can be fatal. This risk may increase with duration of use. Patients with cardiovascular disease or risk factors for cardiovascular disease may be at greater risk.
FLECTOR(R) Patch is contraindicated for the treatment of perioperative pain in the setting of coronary artery bypass graft (CABG) surgery, and in patients with known hypersensitivity to diclofenac.
NSAIDs cause an increased risk of serious gastrointestinal adverse events including bleeding, ulceration, and perforation of the stomach or intestines, which can be fatal. These events can occur at any time during use and without warning symptoms. Elderly patients are at greater risk for serious gastrointestinal events.
FLECTOR(R) Patch should not be given to patients who have experienced asthma, urticaria, or allergic-type reactions after taking aspirin or other NSAIDs. Severe, rarely fatal, anaphylactic-like reactions to NSAIDs have been reported in such patients.
FLECTOR(R) Patch labeling contains similar warnings and precautions as other NSAIDs (ibuprofen, naproxen). Please see complete prescribing information for FLECTOR(R) Patch or visit http://www.FlectorPatch.com for more information.
About Alpharma
Alpharma Inc. is a global specialty pharmaceutical company with leadership positions in products for humans and animals. Alpharma is presently active in more than 60 countries. Alpharma has a growing branded pharmaceutical franchise in the pain market with KADIAN(R) (morphine sulfate extended-release) Capsules and FLECTOR(R) Patch (diclofenac epolamine topical patch) 1.3%. In addition, Alpharma is among the world’s leading producers of several specialty pharmaceutical-grade bulk antibiotics and is internationally recognized as a leading provider of pharmaceutical products for poultry and livestock. For more information, please visit http://www.Alpharma.com.
1. Straus, et al. Gastroenterology. 1999; 116:A97. Abstract G0420.
2. National Center for Health Statistics. Health, United States, 2006. With Chartbook on Trends in the Health of Americans. Hyattsville, MD: 2006.
3. A survey of 1,484 U.S. adults was conducted in December 2007 through a Harris Interactive poll to measure the incidence and types of pain experienced in the last 12 months by adults age 18 and older. Among these, 653 respondents reported “qualifying” pain -- including long term chronic pain, long term recurrent pain, and/or short term acute pain -- and were asked additional questions about how they treat their pain. Unless noted otherwise, statistics in this release focus on recurrent and acute pain sufferers.
LKoen@GolinHarris.com Jack.Howarth@alpharma.com
CONTACT: Media, Lisa Koen of GolinHarris, +1-212-373-6099, cell,
+1-917-273-1944, LKoen@GolinHarris.com, for Alpharma Inc.; or Investor
Relations, Jack Howarth, Vice President, Investor Relations of Alpharma
Inc., +1-908-566-4153, Jack.Howarth@alpharma.com
Web site: http://www.FlectorPatch.com/
http://www.Alpharma.com/
