WASHINGTON (AP) – A new type of antibiotic has been approved by the Food and Drug Administration for the treatment of complicated skin infections that affect millions of patients each year.

The chemical name of the new drug is daptomycin. It will be marketed under the brand name Cubicin by Cubist Pharmaceuticals Inc. of Lexington, Mass.

“This drug is an important contribution to the cache of drugs that doctors can use to treat serious infections,” said Dr. Janice M. Soreth, director of the division of anti-infection drug products at the FDA.

The drug is to be given by injection. It is approved for the treatment of serious infections, usually among hospitalized patients, that involve the skin. These could include abscesses, post-surgical skin wound infections and skin ulcers.

Cubicin is the first of a new class of antibiotics and is part of a continuing effort by industry and government to develop drugs that are more effective against antibiotic-resistant bacteria. Cubicin is specifically approved for treatment of skin infections caused by members of the staphylococcus family of bacteria, including S. aureus, which is a frequent cause of serious and resistant infections. The drug also is indicated for Enterococcus faecalis, which can cause serious systemic infections. The new drug, however, is not indicated for treatment of pneumonia.

Soreth said Cubicin will most commonly be administered in a hospital setting. She said that in 2002 there were about 7 million courses of intravenous antibiotics administered in American hospitals for treatment of serious infections.

Cubicin was approved after clinical studies with 1,400 patients showed it was safe and effective, and was equal to such standard drugs as vancomycin, oxacillin and nafcillin in the treatment of complicated skin and skin structure infections.

Side effects from Cubicin include stomach upset, fever, headache, rash and dizziness, all of which are common, mild reactions patients often have to powerful antibiotics. Soreth said Cubicin also has been shown to cause muscle injury in some rare patients. She said the study showed that patients recover from this problem with no lasting symptoms.

On the Net:

Food and Drug Administration: http://www.fda.gov

AP-ES-09-12-03 1955EDT

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