Market Wire - The First and Only Anti-Inflammatory Pain Relief Patch in the U.S. — FLECTOR(R) Patch — Now Available
Alpharma Inc. (NYSE: ALO), a global
specialty pharmaceutical company, announced today the availability of
FLECTOR 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 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 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 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.
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 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 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 Patch labeling contains similar warnings and precautions as
other NSAIDs (ibuprofen, naproxen). Please see complete prescribing
information for FLECTOR Patch or visit www.FlectorPatch.com for more
information.
About Alpharma
