Oracea phase 3 clinical trials show 'highly significant' results

Newtown, Pa. - CollaGenex Pharmaceuticals announces the "highly significant" positive outcomes of two phase 3, double-blinded, placebo-controlled clinical trials designed to evaluate the safety and efficacy of Oracea for the treatment of rosacea.

The trials enrolled a total of 537 patients in 28 centers across the United States. Patients in the study were administered either Oracea or placebo once a day for 16 weeks.

James Q. Del Rosso, D.O., clinical assistant professor, department of dermatology, University of Nevada School of Medicine, Las Vegas, says, "With millions of patients seeking treatment for rosacea, it is exciting that the studies with Oracea are so impressive. The availability of a systemic treatment for rosacea that is effective, safe and devoid of antibiotic effects, will be a major advance in treatment."

Klaus Theobald, M.D., Ph.D., chief medical officer of CollaGenex, says, "We believe that these results demonstrate an excellent efficacy and safety profile for Oracea, and we expect to file our NDA in the third quarter of 2005."

Colin Stewart, president and chief executive officer, says that if approved by the U.S. Food and Drug Administration, Oracea would be the first systemic treatment for the potentially disfiguring condition and could expand the current $500 million market for prescription drugs to treat rosacea.

Dr. Del Rosso will present data from the clinical trials this month at the American Academy of Dermatology Summer Meeting in Chicago.