APPROVED BY U.S. FOOD AND DRUG ADMINISTRATION FOR PATIENTS TAKING
NSAIDS FOR THE TREATMENT OF ARTHRITIS WHO ARE AT RIST FOR RECURRENT
- First Combination pack of Its Kind Provides New Option-
FOREST, Ill., November 19, 2003 - TAP Pharmaceutica Products Inc.
today announced that the U.S. Food and Drug Administration (FDA)
approved PREVACID NapraPAC (lansoprazole delayed-release capsules and
naproxen tablets kit), a first of its kind combination package
containing two widely used medications in one prescription.
PREVACID NapraPAC contains the nonsteroidal anti-inflammatory drug
(NSAID) NAPROSYN (naproxen tablets) and the acid suppressor PREVACID
(lansoprazole), the most prescribed* proton-pump inhibitor(PPI) in
the U.S., in one convenient package. PREVACID NapraPAC is
indicated for reducing the risk of NSAID-associated gastric ulcers in
patients with a history of a documented gastric ulcer that require
the use of an NSAID for treatment of the signs and symptoms of
rheumatoid arthritis, osteoarthritis and ankylosing spondylitis.
Controlled studies did not extend beyond 12 weeks.
It is estimated that 20 million people in the United States have
osteorathritis (OA) and 2.1 million adults have rheumatoid arthritis
(RA). NSAIDs are commonly prescribed for the relief of pain and
inflammation in these patients. In fact, NSAIDs are the most
prescribed class of medicines in the world.
"NAPROSYN, like most NSAIDs, is vbery effective at relieving
pain associated with arthritis, but it has been recognized as being
associated with serious gastrointestinal side effects, like stomach
ulcers," said A. Mark Fendrick, M.D., associate professor of
Internal Medicine in the School of Medicine at the University of
M8ichigan Health System. "PREVACID NapraPAC represents an
easy-to-use option in one prescription for arthritis patients who
must take anti-inflammatory agents to relieve their pain, but who
also need to reduce the risk of reccurrence of stomach ulcers."
Toxicity and Ulcer Risk
NSAIDs can cause ulcers
by interfering with the stomach's ability to protect itself from
gastric irritants, such as acid. Gastric ulcers are round or
oval sores where the lining of the stomach has been eaten away by
stomach acid and digestive juices. NSAIDs, such as aspirin and
naproxen, can irritate the stomach lining and can cause ulcers.
In the United States, it is estimated that 14 million people take an
NSAID on a daily basis. Approximately 100,000 patients are
hospitalized and between 10,000-20-000 patients die each year from
NSAID-related ulcer complications. The risk of NSAID-induced GI
events is increased two- to four-fold in patients with a history of
prior ulcer disease or complications. This is the most
significant rist factor for NSAID-induced complications.
Shown to Reduce the Risk of Recurrent Gastric Ulcers
multi-center. dpib;e-blind placebo- and misoprostol-controlled study
examined more than 500 patients who required chronic use of NSAIDs
and who had a history of a documented gastric ulcer. Patients
were randomized to received 15 mg or 30 mg PREVACID once daily, 200
mcg misoprostol four times a day or placevo for 12 weeks. Data
from this study demonstrated that significantly more patients
remained ulcer free with PREVACID compared to placebo. In fact,
after 12 weeks of the study, 80 percent of patients on PREVACID
15 mg, 82 percent on PREVACID 30 mg, and 93 percent on misoprostol
200 mcg remained ulcer free compared to only 51 percent taking placebo.
Futhermore, in a dubset analysis of study data from 119 patients, 89
percent of patients taking PREVACID 15 mg plus naproxen, with or
without aspirin, remained free of recurrent stomach ulcers after 12
week versus 83 percent of patients taking misoprostol and 33 percent
taking placebo plus naproxen. Conconitant aspirinwas used in 15
percent of patients.
PRAVACID Napra PAC
PREVACID NapraPAC is available as a daily dose of one PREVACID 15 mg
delayed release capsule and two NAPROSYN tablets of either 375mg or
500 mg. NAPROSYN is an NSAID with analgesic and antipyretic
properties that has been prescribed for over 25 years for relief from
pain associated with conditions such as rheumatoid arthritis,
osteoarthritis, and ankylosing spondylitis.
A monthly course of PREVACID NapraPAC is conveniently supplied in
weekly blister cards. The easy-to-use blister card indicates
which pills to take on which days, an important convenience for
patients. PREVACID NaPraPAC opens easily, and provides simple
and clear directions. The package also meets the Consumer
product Safety Commision's criteria for child-resistance.
PREVACID NapraPAC is contraindicated in patients with known
hypersensitivity to any component of the formulations of lansoprazole
Naproxen is also contraindicated in patients in whom aspirin or
other NSAIDs/analgesic drugs induce the syndrome of asthma, rhinitis,
and nasal polyps. Both types of reactions have the potential of
being fatal. Other naproxen-containg products should not be
Serious GI toxicity such as bleeding, ulceration, and perforation
can occur with or without warning symptoms with chronic NSAID therapy.
the risk-reduction study of PREVACID for NSAID-associated ulcers,
the incidence of diarrhea was 5% and 3% for the PREVACID
and the placebo groups, respectively. Symptomatic response to
PREVACID does not preclude the presence of gastric malignancy.
For further importand information on PREVACID NapraPAC, please see
the complete prescribing information, log onto
www.prevacid.com/naprapac/pi or call 800-622-2011.
TAP Pharmaceutical Products Inc.
TAP Pharmaceutical Products Inc., located in Lake Forest, Ill., is a
joint e\venture between Abbott Laboratories, headquartered in Abbott
Park, Ill., and Takeda Chemical Industries, Ltd., of Osaka,
Japan. TAP also markets Lupron Depot (leuprolide acetate for
more information on TAP Pharmaceutical Products Inc. and its
products, wisit the company's web site at www.tap.com.
NapraPAC are trademakes of Syntex Pharmaceuticals International, Limited.
National Prescription Audit Plus 7 Weekly, November 2003.