Oral, anti-inflammatory rosacea drug: Effective, safe, approved

August 1, 2006

Las Vegas - Rosacea treatment has taken a giant step forward with the Food and Drug Administration's recent approval of Oracea - doxycycline controlled-release capsules made by CollaGenex Pharmaceuticals. Oracea is the first FDA-approved, orally administered, systemically delivered drug to treat rosacea. It was approved for the treatment of inflammatory papules and pustules of rosacea in adult patients, and is currently available to dermatologists.

James Q. Del Rosso, D.O., clinical associate professor, department of dermatology, University of Nevada School of Medicine, Las Vegas, points out that Oracea's availability provides a convenient, effective and safe oral therapy option that works through anti-inflammatory activity and does not produce any antibiotic effects. Oracea is the only oral formulation available that can make that claim, he adds.

Two pivotal, 16-week, double-blind, phase 3 clinical studies comparing controlled-release once-a-day doxycycline (40 mg) to placebo provided the basis of Oracea's FDA approval. A total of 537 patients were enrolled in 28 centers across the United States. At baseline, Oracea and placebo patients had a mean lesion count of 20.0 and 20.8, respectively. Using the Investigator's Global Assessment (IGA) score, a subjective five-point scale measuring disease severity, more than 90 percent of all patients in both treatment groups were characterized as moderately-to-severely affected.

Both studies achieved their primary endpoint by demonstrating a greater reduction in inflammatory lesion count from baseline for the Oracea-treated patients compared to the placebo controls. In the two studies, patients receiving Oracea experienced a 61 percent and 46 percent mean reduction in inflammatory lesions compared to 29 percent and 20 percent, respectively, in patients receiving placebo. The differences were clinically and statistically highly significant (p<0.001 in each study). Dr. Del Rosso was a clinical investigator in the Oracea clinical trials.

Dr. Del Rosso describes the results of the secondary endpoints of change in the Oracea's IGA score and the dichotomized IGA at week 16, which measured the percentage of patients who were clear or near clear at the end of the study. Oracea-treated patients fared much better than placebo patients, as evidenced by a highly statistically significant change from baseline in IGA in both trials (p<0.001 and p=0.004). In the analysis of dichotomized IGA in both studies, there were a statistically significant greater number of patients who were clear or near clear at the end of the study in the Oracea group compared to the placebo group (p=0.036 and p=0.012).

Another secondary endpoint for improvement of rosacea in both clinical trials with Oracea was reduction in erythema. In the second study, erythema reduction achieved statistical significance, with a greater reduction in the study group treated with Oracea as compared to the placebo arm at week 16 (p=0.017).

Convenience, compliance

Dr. Del Rosso points out that the convenience of Oracea's once-daily dosing should not be underestimated.

"Compliance data show that when patients only have to do something once a day, they're more likely to comply than if the regimen calls for two or more daily doses or applications," he says.