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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%.

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)

Treatment satisfaction:8

  • 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

Side Effect Percentage
Skin and Subcutaneous Tissue Disorders 2.7%
Nausea 1.3%
Diarrhea 1.2%
Headache 1.0%
Fungal Infections 0.4%
Photosensitivity 0.1%

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