Oracea is indicated to reduce papulopustular lesions in adult patients with facial rosacea. It is a low-dose doxycycline treatment (40 mg/day), given when local treatment is inadequate.
Treatment with low-dose doxycycline cause a clinically relevant reduction in observed number of lesions compared with placebo. Doxycycline 40 mg/day vs. 100 mg/day has shown comparable reductions in observed number of lesions when prescribed in combination with locally acting metronidazole. Oracea has not been compared with other relevant high-dose alternatives. Low-dose doxycycline allegedly has a more favorable adverse drug reaction profile compared to high-dose alternatives.
Based on efficacy, safety profile and price IRF find that Oracea is a relevant treatment alternative to high-dose doxycycline/tetracycline for treating rosacea. The cost of three months of treatment is higher than the cheapest treatment with tetracycline. However, low-dose doxycycline has a more favorable safety profile without increased incidence of resistance.
Oracea capsules of 40 mg cost 361.30 Dkr (56 unit package). Oracea was marketed on September 5th 2011. At the present time Oracea is not subject to reimbursement.
Institut for Rationel Farmakoterapi 20-09-2011