PHARMACY

Research suggests antioxidant effective against diabetes

BY Drew Buono

LONDON According to the May 24 issue of The Lancet, a new antioxidant drug, succinobucol, has shown the ability to prevent and treat diabetes. Researchers also say that more research on possible cardiovascular risks is needed before it is widely used.

Succinobucol is a chemical relative of probucol, a cholesterol-lowering drug taken off the market in the United States in 1995 because of side effects. In addition to its antioxidant effects, succinobucol also reduces inflammation.

The trial included 6,144 people, 37 percent of whom had diabetes and all of whom had been hospitalized for a heart attack or the dangerous heart rhythm problem called unstable angina. For two years, half of the participants took succinobucol daily, while the other half took a placebo. All were taking other drugs, such as cholesterol-lowering statins, beta blockers or ACE inhibitors.

Among the participants who did not have diabetes when the study began, 4.2 percent of those not taking succinobucol developed the disease, compared to 1.64 percent of those taking the drug, a 64 percent risk reduction. For those with diabetes, taking succinobucol provided better blood sugar control than not taking the drug.

Atrial fibrillation, a dangerous heartbeat abnormality, was twice as likely to develop during the trial in those taking succinobucol. There was no difference in the incidence of death, cardiac arrest, heart attack, stroke or other cardiovascular endpoints between those taking or not taking the drug.

“The study results need confirmation before it is used widely, because there was no effect on those clinical endpoints,” said study author Jean-Claude Tardif, director of the research center at the Montreal Heart Institute in Canada. “But that is true of all the drugs now used in diabetes. There is no evidence that they reduce heart attacks and strokes.”

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FDA approves Teva’s generic Sarafem Pulvules

BY Alaric DeArment

JERUSALEM The Food and Drug Administration has granted final to Teva Pharmaceuticals to market a drug for treating premenstrual dysphoric disorder.

The drug, fluoxetine, is a generic version of Eli Lilly’s drug Sarafem Pulvules. The FDA granted approval for Teva’s application for 10 mg and 20 mg capsules of the drug Wednesday. The FDA granted a first-to-file 180-day marketing exclusivity to Teva. The drug will ship immediately.

Teva, headquartered in Israel, is a manufacturer of generic drugs and one of the 20 largest pharmaceutical companies in the world. Teva North America operates in California, Missouri, Florida, New York, New Jersey and Pennsylvania.

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FDA issues approvable letter for Wyeth osteoporosis drug

BY Alaric DeArment

WASHINGTON Wyeth Pharmaceuticals received an approvable letter from the Food and Drug Administration for a drug to treat postmenopausal osteoporosis, the company announced Friday.

The FDA requested further analysis concerning stroke and venous thrombosis for the drug, known as bazedoxifene. The FDA made similar requests when Wyeth Pharmaceuticals filed a new drug application in December 2007. The company expects to respond to the new letter by the end of this year.

Wyeth Pharmaceuticals is a division of Wyeth, a global company specializing in pharmaceuticals, consumer healthcare products and animal healthcare products.

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