FDA Approves New Beta Blocker To Treat High Blood Pressure

Main Category: Hypertension
Also Included In: Regulatory Affairs / Drug Approvals
Article Date: 19 Dec 2007 - 3:00 PDT

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The U.S. Food and Drug Administration has approved Bystolic (nebivolol) for the treatment of high blood pressure.

Bystolic is a beta blocker, a well-established class of medications that reduces blood pressure by reducing the force with which the heart pumps. It is a new drug not previously approved in the United States.

Nearly one in three adults in the United States has high blood pressure, also called hypertension, which can increase the risks for stroke, heart failure, heart attack, kidney failure, and death.

"High blood pressure is often called the 'silent killer' because it usually has no symptoms until it causes damage to the body," said Douglas C. Throckmorton, M.D., FDA's deputy director of the Center for Drug Evaluation and Research. "Bystolic offers a new treatment option for people who need to control their high blood pressure."

The safety and efficacy of Bystolic in lowering blood pressure was assessed in three randomized, double-blind, multi-center, placebo-controlled clinical trials that ran for up to three months.

A fourth placebo-controlled clinical trial demonstrated additional blood pressure-lowering effects when Bystolic was given with up to two other antihypertensive medications in patients with inadequate blood pressure control. In total, more than 2,000 people received Bystolic during the trials. Its efficacy during the trials was similar to those of other FDA-approved beta blockers.

The most common side effects reported by patients taking Bystolic in clinical trials were headache, fatigue, dizziness and diarrhea.

Mylan Bertek Pharmaceuticals Inc. of Research Triangle Park, N.C., is the sponsor of Bystolic. New York City-based Forest Laboratories, Inc. owns the rights for the sales and marketing of the drug.

What is High Blood Pressure? - National Heart Lung and Blood Institute

http://www.fda.gov