14 CLINICAL STUDIES
MIRVASO topical gel was eva luated for the treatment of moderate to severe, persistent (nontransient) facial erythema of rosacea in two randomized, double-blind, vehicle-controlled clinical trials, which were identical in design. The trials were conducted in 553 subjects aged 18 years and older who were treated once daily for 4 weeks with either MIRVASO topical gel or vehicle. Overall, 99% of subjects were Caucasian and 76% were female. Baseline disease severity was graded using a 5-point Clinical Erythema Assessment (CEA) scale and a 5-point Patient Self Assessment (PSA) scale, on which subjects scored either “moderate” or “severe” on both scales.
The primary efficacy endpoint in both pivotal trials was 2-grade Composite Success, defined as the proportion of subjects with a 2-grade improvement on both CEA and PSA measured at hours 3, 6, 9, and 12 on Day 29. Table 2 presents the efficacy results. In addition to Day 29, efficacy was eva luated on Day 15 and Day 1, and the results are presented in Figures 1 and 2 for Studies 1 and 2, respectively.
Table 2: Summary of 2-grade Composite Success on Day 29
|
2-grade Composite Success: 2-grade improvement on CEA and 2-grade improvement on PSA. |
|
Success |
Study 1 |
Study 2 |
|
|
MIRVASO Topical Gel
(N=129)
|
Vehicle Gel
(N=131)
|
MIRVASO Topical Gel
(N=148)
|
Vehicle Gel
(N=145)
|
|
Hour 3 |
31% |
11% |
25% |
9% |
|
Hour 6 |
30% |
10% |
25% |
9% |
|
Hour 9 |
26% |
10% |
18% |
11% |
|
Hour 12 |
23% |
9% |
22% |
10% |
Figure 1: 2-grade Composite Success by Hour and Day for Study 1
Figure 2: 2-grade Composite Success by Hour and Day for Study 2
16 HOW SUPPLIED/STORAGE AND HANDLING
MIRVASO (brimonidine) topical gel, 0.33% is a white to light yellow opaque gel, supplied in a laminated tube with a child resistant cap in the following sizes:
30 gram NDC 0299-5980-30
45 gram NDC 0299-5980-45
Store at 20°C to 25°C (68°F to 77°F), excursions permitted between 15°C and 30°C (59°F and 86°F) [See USP Controlled Room Temperature].
17 PATIENT COUNSELING INFORMATION
See FDA-approved patient labeling (Patient Information and Instructions for Use)
Patients using MIRVASO topical gel should receive the following information and instructions:
-
This medication is to be used as directed by the physician.
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It is for external use only.
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MIRVASO topical gel should not be applied to irritated skin or open wounds.
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Avoid contact with the eyes and lips.
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Patients should wash their hands immediat
