FDA Approves Oracea to help treat rosacea in adults.

On May 31, 2006, the FDA approved a new drug, Oracea, for treatment of rosacea in adults.

Oracea can be used to treat the inflammatory lesions (papules and pustules) in adults with rosacea

It comes in 40 milligram capsules designed to be taken once daily. Oracea will be available by prescription in July, according to information presented by Collagenex Pharmaceuticals, which makes the drug.

A news release from CollaGenex states that Oracea is a “unique capsule formulation of doxycycline” taken once daily. Doxycycline is an antibiotic. The dose in Oracea differs from the usual dosage used to treat infections.

Oracea was approved based on two studies that included 537 patients in 28 centers across the U.S. Patients either received Oracea or an empty drug (placebo), without knowing which was which.

“In the two studies, patients receiving Oracea experienced a 61% and 46% mean (average) reduction in inflammatory lesions compared to 29% and 20% mean (average) reduction, respectively, in patients receiving placebo,” states the CollaGenex news release.

Side Effects

In Oracea’s clinical trials, “side effects of the drug were similar to placebo,” states the CollaGenex news release.

Oracea’s label also warns that Oracea shouldn’t be used during pregnancy. Doxycycline is in the family of drugs that includes tetracycline.

“Doxycycline, like other tetracycline-class antibiotics, can cause fetal harm when administered to a pregnant woman,” states the drug’s label.

If you suffer from rosacea, be sure to ask your doctor if Oracea might be right for you.