Abbott's new formulation of Tricor tabs approved for common lipid disorders
Abbott announced has been granted US FDA approval to market a new formulation of TriCor (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 per cent 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, Abbott said in a press release here.
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, associate professor of Medicine and Pharmacology and director of Preventative Cardiology and Atherosclerosis Research at Rush University Medical Centre in Chicago.
According to the National Cholesterol Education Programme (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, total cholesterol, triglycerides and apolipoprotein B, and increases HDL 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," saidPeter Jones, 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.
Abbott markets TriCor in the US through an agreement with Fournier of France.