ORACEA Capsules provided early and consistent inflammatory lesion reduction
A multicenter, outpatient, double-blind, placebo-controlled, parallel-group trial was conducted over 16 weeks to evaluate the safety and efficacy of ORACEA. A total of 251 rosacea subjects (≥18 years of age with 10 to 40 papules and pustules and ≤2 nodules, plus an investigator’s global assessment [IGA] score of 2 to 4) participated.
1 of 2 studies:
In pivotal clinical studies, the most common treatment-related adverse events (≥2%) were nasopharyngitis (4.8%), diarrhea (4.5%), hypertension (3%), sinusitis (2.6%), and aspartate aminotransferase increase (2.2%).
ORACEA Capsules demonstrate clinical efficacy equivalent to an antimicrobial dose (100 mg) of doxycycline
A randomized, multicenter, outpatient, double-blind, active-controlled, non-inferiority trial of 91 patients (≥18 years of age) over 16 weeks. Subjects were prospectively randomized to receive daily doses of either 40-mg ORACEA or 100-mg doxycycline, each with MetroGel® (metronidazole) Gel 1%.
In this clinical study, the most common treatment-related adverse events for ORACEA Capsules were swollen tongue, tongue disorder, seasonal allergy, pruritus, skin burning sensation, and urticaria, all occurring at ≥2%.
Patients experienced NO nausea, NO diarrhea and NO vomiting vs. Doxycycline 100 mg4
|ORACEA Capsules 40mg||0%||0%||0%|
Consistent results independent of patient body weight and number of lesions
Post-hoc analysis of data from a multicenter, double-blind, placebo-controlled trial, which was conducted over 16 weeks to evaluate the safety and efficacy of ORACEA Capsules. The subgroup analysis was based on pooled data from 2 Phase 3 trials to evaluate the impact of weight on efficacy for ORACEA Capsules in reducing inflammatory lesions.1,2
In pivotal clinical studies, the most common treatment-related adverse events (≥2%) were nasopharyngitis (4.8%), diarrhea (4.5%), hypertension (3%), sinusitis (2.6%) and aspartate aminotransferase increase (2.2%).1
ORACEA Capsules were proven effective in the largest community rosacea trial to date
In the ORCA (ORACEA Capsules for Rosacea: a Community-based Assessment) Trial:
- Monotherapy with ORACEA Capsules (n=1,196)6: 74.6% of subjects were clear or near clear by week 12 (n=826 per-protocol population)
- ORACEA Capsules as add-on therapy (n=224)7: 75.7% of subjects were clear or near clear by week 12 (n=140 per-protocol population)
- 90.4% of the community-based investigators reported they were likely or very likely to continue prescribing ORACEA Capsules
- 81.3% of subjects were satisfied or very satisfied with ORACEA Capsules as monotherapy
- 79.3% of subjects were satisfied or very satisfied with ORACEA Capsules as add-on therapy
The most commonly reported treatment-related AEs in subjects treated with ORACEA Capsules as monotherapy in the ORCA trial were mild to moderate and included:5
|Skin and Subcutaneous Tissue Disorders||2.7%|