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Alfuzosin Earns Nod From FDA

Kate Traynor

Sanofi-Synthelabo announced yesterday that the Food and Drug Administration (FDA) has approved the marketing of alfuzosin hydrochloride for the treatment of the signs and symptoms of benign prostatic hyperplasia.

Alfuzosin, a selective blocker of alpha-1 adrenergic receptors in the lower urinary tract, improves urine flow in men with benign prostatic hyperplasia by causing relaxation of smooth muscle in the bladder neck and prostate gland.

According to a Sanofi-Synthelabo press release, the most common adverse events among alfuzosin users during the clinical studies were dizziness, upper-respiratory-tract infection, headache, and fatigue. Patients with moderate to severe liver insufficiency should not use the product. Alfuzosin should be used with caution in patients with severe kidney disease. The company said the drug should not be administered with another alpha-blocker or with potent inhibitors of cytochrome P-450 isoenzyme 3A4.

Various formulations of alfuzosin are marketed outside the United States under the trade name Xatral. The FDA-approved, 10-mg extended-release tablet formulation is produced using drug-delivery technology developed by SkyePharma P.L.C. The extended-release formulation is administered once daily.

Although a press release from SkyePharma stated that alfuzosin will be sold in the United States under the trade name UroXatral, a spokesman for Sanofi-Synthelabo said that no final decision has been made on the U.S. product name.

Sanofi-Synthelabo expects alfuzosin to be available in pharmacies during the second half of 2003.