Abbott Receives FDA Approval for New Formulation of TriCor(R) (Fenofibrate) Tablets for the Treatment of Common Lipid Disorders

- Nanoparticle Technology Now Allows TriCor to Be Taken With or Without Food -

Nov 05, 2004, 00:00 ET from Abbott

    ABBOTT PARK, Ill., Nov. 5 /PRNewswire-FirstCall/ -- Abbott (NYSE:   ABT)
 announced today that it received U.S. Food and Drug Administration approval to
 market a new formulation of TriCor(R) (fenofibrate) Tablets for the treatment
 of lipid disorders such as mixed dyslipidemia -- conditions related to
 abnormal levels of fats, including cholesterol and triglycerides, in the
 bloodstream.  The new formulation of TriCor was developed using a new
 nanoparticle technology so it can be taken with or without food.
     Until now, TriCor had to be taken with food to enable optimal absorption
 of TriCor in the body.  Taking the previous version of TriCor with food
 compared to without food could result in an approximate 35 percent difference
 in the body's absorption of the medicine.  New TriCor 145 milligram (mg) and
 48 mg tablets offer the same effectiveness at a lower dosage strength than the
 previous 160 mg and 54 mg tablets, but now can be taken with or without food,
 increasing convenience for the patient.  TriCor remains a once-daily
     Nanoparticle technology was applied in the development of the new
 formulation of TriCor to allow the drug to dissolve faster and more completely
 in the gastrointestinal tract, which makes the drug more easily absorbed by
 the body.
     "Patients with lipid disorders may also be on multiple medications, and
 the failure to take these medications as prescribed can cause patients to miss
 the full benefits of treatment," said Michael Davidson, M.D., associate
 professor of Medicine and Pharmacology and director of Preventative Cardiology
 and Atherosclerosis Research at Rush University Medical Center in Chicago.
 "One of the ways to improve patient convenience is to make it easier to take a
 drug as prescribed."
     According to the National Cholesterol Education Program (NCEP) Adult
 Treatment Panel III Guidelines, simplifying treatment regimens is recommended
 as one of many key components to improve adherence.
     TriCor, in addition to appropriate diet, is used to treat adults with high
 cholesterol and/or mixed dyslipidemia, with or without elevated triglycerides,
 after results of lifestyle changes are unsuccessful.  TriCor reduces elevated
 LDL cholesterol ("bad" cholesterol), total cholesterol, triglycerides and
 apolipoprotein B, and increases HDL cholesterol ("good" cholesterol).
     A recent report published in Circulation, which proposes changes to the
 NCEP Adult Treatment Panel III Guidelines, stated that one class of drugs that
 modestly raises HDL cholesterol is the fibrate class.  The report also
 suggests that treatment with fibrates, a class of drugs that includes
 fenofibrate, may have a complementary role in the treatment of patients with
 high triglycerides and low HDL cholesterol.
     "Using TriCor can offer doctors another option for difficult-to-treat
 patients, such as those who have multiple lipid disorders, including elevated
 triglycerides, elevated LDL cholesterol and low HDL cholesterol," said Peter
 Jones, M.D., associate professor of Medicine at the Baylor College of
     TriCor 145 mg and 48 mg tablets will replace the TriCor 160 mg and 54 mg
 tablets currently on the market.  Pricing for the new dosages remains the same
 as pricing for the current dosages.
     In the U.S., more than one million patients have taken TriCor in 2004.
 Abbott markets TriCor in the U.S. through an agreement with Fournier of
     About Cholesterol and Triglycerides
     Cholesterol is a natural, waxy, fat-like substance found in the body.
 There are two sources of cholesterol in the body.  Some cholesterol is made in
 the liver, and the rest comes primarily from animal products that are eaten,
 such as meats, poultry and cheese.
     Elevated LDL cholesterol can lead to heart attacks and other
 cardiovascular-related problems.  Unlike high LDL cholesterol, a high HDL
 cholesterol level is considered good because it can often help reduce the
 risks for heart disease.  Triglycerides are another type of fat in the
 bloodstream.  It is not clear whether high triglycerides alone increase the
 risk of heart disease.  However, an excessive amount of triglycerides can be a
 medical concern.  The independent effect of raising HDL cholesterol or
 lowering triglycerides on the risk of cardiovascular morbidity and mortality
 has not been determined with TriCor.
     TriCor Safety Information
     TriCor tablets are not for everyone.  TriCor should not be taken by people
 with serious liver, kidney or gallbladder disease, or by those who may be
 allergic or sensitive to the drug.
     The combined use of TriCor and statin drugs is not advised since it may
 produce potentially serious side effects that could lead to acute renal
 failure.  Therefore, it is important for a health care professional to
 determine if the benefits of the combined use of these drugs are likely to
 outweigh the increased risks of the drug combination.
     TriCor tablets may cause changes in laboratory reports, especially in
 liver chemistry results.  Regular periodic liver tests should be performed
 while patients are taking TriCor.  Patients should contact their doctors if
 they feel pain in the stomach area while taking TriCor, as this can be a sign
 of gallstones or inflammation of the pancreas.  TriCor may cause muscle pain
 or serious muscle disease, allergic type reactions and possible changes in
 blood chemistry.  If patients experience unexpected muscle pain, tenderness or
 weakness while taking TriCor, a health care provider should be contacted
     Patients should notify their doctor if they are taking any other drugs
 while taking TriCor including any other cholesterol-lowering medications.
 TriCor may have an effect on drugs that help prevent blood clotting, such as
 the blood thinner Coumadin(R) (warfarin sodium tablets, USP), and doctors
 should monitor blood-clotting tests more frequently.
     Patients should tell their doctors about any side effects they experience,
 including breathing problems, back pain and headaches.
     For more information about TriCor (fenofibrate) Tablets, including full
 prescribing information, please visit .
     Coumadin is a registered trademark of Bristol-Myers Squibb Company.
     Abbott is a global, broad-based health care company devoted to the
 discovery, development, manufacture and marketing of pharmaceuticals and
 medical products, including nutritionals, devices and diagnostics.  The
 company employs more than 55,000 people and markets its products in more than
 130 countries.
     Abbott's news releases and other information are available on the
 company's Web site at .