FHRX First Horizon Pharmaceutical (MM)

Fenofibrates Treat Elevated Triglycerides and Cholesterol ALPHARETTA, Ga., Jan. 19 /PRNewswire-FirstCall/ -- The study, sponsored by First Horizon Pharmaceutical Corporation (NASDAQ:FHRX), will be published in the January 2006 issue of Clinical Therapeutics and online at http://www.clinicaltherapeutics.com/xpress.html?37758293.963939756 . The open-label study to evaluate the effect of administering a single dose of Niaspan* (niacin extended-release tablets), Zocor** (simvastatin) and Lipitor*** (atorvastatin calcium) on the pharmacokinetics and safety of a single dose of TRIGLIDE(TM) (fenofibrate) tablets in 20 healthy male and female adults showed that there were no significant effects on the pharmacokinetics of TRIGLIDE when taken alone or in combination with simvastatin or atorvastatin. TRIGLIDE, a fibric acid derivative (fibrate), is an adjunctive therapy to diet for hypercholesterolemia or mixed dyslipidemia (Frederickson Types IIa and IIb) and hypertriglyceridemia (Frederickson Types IV and V hyperlipidemia). According to the National Cholesterol Education Program guidelines, fibrates primarily target atherogenic dyslipidemia (low HDL cholesterol, elevated triglycerides and possibly small LDL particles). A combination of statins and fibrates improves the overall lipoprotein profile compared to either fibrates or LDL-lowering drugs alone. This finding has led to a movement for considering use of fibrates in combination with statins in high-risk individuals whose triglyceride levels are still elevated. In some persons, this combination may better achieve the secondary target for non-HDL cholesterol than will statins alone.(1) About the TRIGLIDE Combination PK Study The open-label, single-center, randomized study was a four-treatment, four-period crossover study in 20 healthy male and female volunteers to determine the effect of a single dose of atorvastatin (10 mg), simvastatin (10 mg), or extended-release niacin (500 mg) on the pharmacokinetics and safety of a single dose of TRIGLIDE - fenofibrate Insoluble Drug Delivery(R)- microparticle (IDD(R)-P), 160 mg tablet. The concomitant administration of atorvastatin or simvastatin had no significant effect on the pharmacokinetics of a single dose of TRIGLIDE. However, a drug interaction between concomitantly administered single doses of TRIGLIDE and extended release niacin could not be ruled out. In addition, although TRIGLIDE was generally well-tolerated, one subject experienced a possibly related serious adverse event, a seizure, approximately 12-hours post-administration of IDD-P fenofibrate plus atorvastatin. According to the product's Prescribing Information, there have been no other incidences of seizure associated with TRIGLIDE to date.(2) About TRIGLIDE TRIGLIDE belongs to a class of drugs called fibric acid derivatives. After lifestyle changes with diet and exercise have not shown to be effective, fenofibrates may be prescribed in addition to eating a healthy diet low in saturated fat and cholesterol to help control triglycerides, LDL-cholesterol, and apolipoprotein B (Apo B). TRIGLIDE is indicated as adjunctive therapy to diet for the reduction of LDL-C, total-C, triglycerides and Apo B in adult patients with primary hypercholesterolemia or mixed dyslipidemia (Frederickson Types IIa and IIb). It is also indicated as adjunctive therapy to diet for the treatment of adult patients with hypertriglyceridemia (Frederickson Types IV and V). TRIGLIDE 50 mg and 160 mg tablets are taken once daily, with or without meals, for convenient, simple dosing. In a single-dose pharmacokinetics study in healthy volunteers, TRIGLIDE 160 mg tablet was shown to have comparable bioavailability to a single dose of 200 mg fenofibrate, micronized. Lipid-altering agents should be used in addition to a diet restricted in saturated fat and cholesterol, when response to diet and non-pharmacologic interventions alone have been inadequate. TRIGLIDE administration is contraindicated for patients with known hypersensitivity to fenofibrate or any of the formulation components, severe renal dysfunction, pre-existing gallbladder disease, and/or hepatic dysfunction, including primary biliary cirrhosis and unexplained persistent liver function abnormality. Caution should be exercised when coumarin-anticoagulants are given in conjunction with TRIGLIDE. The extent of absorption as measured by the area under the curve (AUC) is comparable between fed and fasted conditions. Food increases the rate of absorption of TRIGLIDE approximately 55 percent. The combined use of TRIGLIDE and HMG-CoA reductase inhibitors should be avoided unless the benefit of further alteration in lipid levels is likely to outweigh the increased risk of this drug combination. TRIGLIDE has not been investigated in adequate and well-controlled trials in geriatric patients. In the elderly or patients with impaired renal function, treatment with TRIGLIDE should be initiated at a dose of 50 mg/day and increased only after evaluation of the effects of renal functions and lipid levels at this dose. The most commonly observed side effects seen in fenofibrate therapy are abnormal liver function test results, respiratory disorders, and abdominal pain. Please visit http://www.fhrx.com/ for full prescribing information or call 1-800-849-9707 to speak with Medical Affairs. About First Horizon Pharmaceutical Corporation First Horizon Pharmaceutical Corporation is a specialty pharmaceutical company that markets, sells and develops prescription products, with a primary focus on cardiology and women's health. First Horizon's portfolio includes 15 branded prescription products, of which 8 are actively promoted to physicians through its nationwide sales force of approximately 470 representatives. For more information about First Horizon Pharmaceutical Corporation, please visit http://www.fhrx.com/ or call 1-800-849-9707. 1. National Cholesterol Education Program Third Report of the expert panel on detection, evaluation, and treatment of high blood cholesterol in adults. NIH Pub. No. 02-5215. Bethesda, MD: National Heart, Lung, and Blood Institute 2002, 284 pages. 2. First Horizon Pharmaceutical Corporation, Package Insert, rev. 01/05 * Niaspan is a registered trademark of Kos Pharmaceuticals, Inc. ** Zocor is a registered trademark of Merck & Co., Inc. *** Lipitor is a registered trademark of Parke-Davis DATASOURCE: First Horizon Pharmaceutical Corporation CONTACT: Marilyn Seiger for First Horizon Pharmaceutical Corporation, +1-203-762-8833,

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