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Published on 1/19/2006 in the Prospect News Biotech Daily.

First Horizon study shows cholesterol-lowering Triglide well tolerated

By Lisa Kerner

Erie, Pa., Jan. 19 - First Horizon Pharmaceutical Corp. said an 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 its Triglide (fenofibrate) tablets showed Triglide to be well tolerated, according to a company news release.

The single-center, randomized study was a four-treatment, four-period crossover study in 20 healthy male and female volunteers. No significant effects were found on the pharmacokinetics of a single dose of Triglide (160 mg tablet) when taken alone or in combination with simvastatin (10mg), atorvastatin (10mg) or extended-release niacin (500mg).

However, a drug interaction between concomitantly administered single doses of Triglide and extended release niacin could not be ruled out, said the release.

Triglide was well tolerated except in only one subject who experienced a possibly related seizure 12-hours post administration, according to the release.

Triglide is a fibric acid derivative (fibrate) used in conjunction with diet to control triglycerides and cholesterol.

First Horizon will publish the study results in the January 2006 issue of Clinical Therapeutics.

Alpharetta, Ga.-based First Horizon is a specialty pharmaceutical company that markets, sells and develops prescription products, with a primary focus on cardiology and women's health.


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