Mechanism of Action
The absorption of brimonidine from MIRVASO topical gel was evaluated in a clinical trial in 24 adult subjects with facial erythema associated with rosacea. All enrolled subjects received once daily topical application of MIRVASO topical gel 1 gram to the entire face for 29 days. Pharmacokinetic assessments were performed on Day 1, Day 15, and Day 29. The mean plasma maximum concentration (Cmax) and area under the concentration-time curve (AUC) were highest on Day 15, with Cmax and AUC values (± standard deviation) of 46 ± 62 pg/mL and 417 ± 264 pg.hr/mL respectively. The systemic drug exposure was slightly lower on Day 29 indicating no further drug accumulation.
Brimonidine is extensively metabolized by the liver.
Urinary excretion is the major route of elimination of brimonidine and its metabolites.
MIRVASO topical gel was evaluated 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 5point 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 evaluated 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
|Success||Study 1||Study 2|
|MIRVASO Topical Gel
|MIRVASO Topical Gel
|2-grade Composite Success: 2-grade improvement on CEA and 2-grade improvement on PSA.|
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
Last reviewed on RxList: 9/6/2013
This monograph has been modified to include the generic and brand name in many instances.
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