Rosacea is a skin disorder known for patchy flushing (redness) and inflammation, particularly on the cheeks, nose, forehead, and around the mouth. Rosacea may also include small, red, solid bumps -- called papules -- and pus-filled pimples -- called pustules -- on the skin.
The FDA approved Oracea to treat inflammatory lesions (papules and pustules) in adults with rosacea.
Oracea comes in 40-milligram capsules taken once daily and will be available by prescription in July, according to a news release from the drug's maker, CollaGenex Pharmaceuticals, Inc. About the Drug
CollaGenex states that Oracea is a "unique capsule formulation of doxycycline" taken once daily. Doxycycline is an antibiotic.
Oracea's doxycycline dose differs from the usual dose used to treat infections. Oracea's formulation has not been evaluated as an antibacterial treatment for infections, states the drug's label.
According to CollaGenex, 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.
In Oracea's clinical trials, "side effects of the drug were similar to placebo," states the CollaGenex news release.
"Doxycycline, like other tetracycline-class antibiotics, can cause fetal harm when administered to a pregnant woman," states the drug's label.
Tetracycline drugs may cause permanent discoloration of teeth if taken during tooth development, which happens in a fetus during the last half of pregnancy and in infants and kids up to 8 years old. For that reason, those drugs shouldn't be used while teeth are developing unless other drugs aren't likely to be effective or can't be taken for other reasons, states Oracea's label.
The FDA's approval letter for Oracea states that CollaGenex has committed to do postmarketing studies related to Oracea's effects on human sperm in male patients with rosacea and on cancercancer. The sperm study is due for submission in two years; the cancer study is due in early 2010, according to the FDA.