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Home » Drug Information » FDA Approved Drugs » 2013
Medical Areas: Dermatology

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Mirvaso (brimonidine)

The following drug information is obtained from various newswires, published medical journal articles, and medical conference presentations.

Company: Galderma Labs
Approval Status: Approved August 2013
Treatment Area: facial erythema of rosacea

General Information

Mirvaso is a once daily topical gel formulation of brimonidine, an alpha-2 adrenergic agonist with potent vasoconstrictive activity.

Mirvaso is specifically indicated for the topical treatment of persistent (nontransient) erythema of rosacea in adults 18 years of age or older.

Mirvaso is supplied as a gel for topical administration. The recommended dose and administration of Mirvaso is as follows: a pea-size amount once daily to each of the five areas of the face: central forehead, chin, nose, each cheek. Mirvaso topical gel should be applied smoothly and evenly as a thin layer across the entire face avoiding the eyes and lips.

Clinical Results

FDA Approval
The FDA approval of Mirvaso was based on two identical randomized, double-blind, placebo-controlled clinical trials 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 placebo. 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 Clinical Erythema Assessment (CEA) and Patient Self Assessment (PSA) measured at hours 3, 6, 9, and 12 on Day 29. The results are as follows (Mirvaso vs. placebo, respectively): Study 1 Hour 3: 31% vs. 11%; Hour 6: 30% vs. 10%; Hour 9: 26% vs. 10% and Hour 12: 23% vs. 9%. Study 2 Hour 3: 25% vs. 9%; Hour 6: 25% vs. 9%; Hour 9: 18% vs. 11% and Hour 12: 22% vs. 10%.

Side Effects

Adverse events associated with the use of Mirvaso may include, but are not limited to the following:

  • erythema
  • flushing
  • skin burning sensation
  • contact dermatitis

Mechanism of Action

Mirvaso (brimonidine) is a relatively selective alpha-2 adrenergic agonist. Topical application of Mirvaso gel may reduce erythema through direct vasoconstriction.

Additional Information

For additional information regarding Mirvaso or rosacea, please visit the GaldermaUSA web page.