FDA Approves New Formulation of TriCor(R) Tablets for Common Lipid Disorders

Main Category: Cholesterol
Article Date: 06 Nov 2004 - 12:00 PST


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 treatment.

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 Medicine.

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 France.

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 immediately.

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 http://www.TriCortablets.com .

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 http://www.abbott.com.

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