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Evaluating the Efficacy and Safety of Once-Daily Anti-Inflammatory,Dose Doxycycline for the Treatment of Rosacea

NEWTOWN, Pa.--(BUSINESS WIRE)--Apr 30, 2007 - CollaGenex Pharmaceuticals, Inc. (NASDAQ:CGPI) today announced that a new report in the May 2007 issue of the Journal of the American Academy of Dermatology evaluating two randomized phase III clinical trials, demonstrated the efficacy and safety of anti-inflammatory dose doxycycline (Oracea(R), 40-mg doxycycline, USP capsules) for the treatment of rosacea. This report has concluded these studies establish the first important body of evidence supporting the use of a systemic therapy for rosacea that is devoid of antibiotic activity.

The study further concludes that "the antibacterial effects of doxycycline or other antibiotics have not been shown to be of therapeutic importance in rosacea, therefore an effective and safe formulation of this drug that does not exhibit antibiotic selection pressure is clinically significant."

Lead clinical investigator in these clinical trials, James Q. Del Rosso. DO, Department of Dermatology, University of Nevada School of Medicine, states, "This discussion of the significance of these phase III studies is of utmost importance to the way in which rosacea patients are treated going forward. The option of an effective systemic treatment for rosacea that is devoid of antibiotic activity helps dermatologists reduce their use of antibiotics. Antibiotic use correlates with a rise in bacterial resistance, a problem of global concern." Anti-inflammatory dose doxycycline was proven to be safe in both studies. The frequency of adverse events was similar to those of patients taking placebo. Of significant note was the finding that in both studies vaginal candidiasis and photosensitivity were not observed in the patients treated with anti-inflammatory dose doxycycline.

Also noteworthy was the fact that once daily dosing, based on a review of several studies, appears to be the dosing regimen associated with the highest rate of pati
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