MIRVASO gave participants in clinical trials fast, lasting relief from the erythema of rosacea1,2
MIRVASO® (brimonidine) topical gel, 0.33%* was studied in two 4-week pivotal trials and a
In the pivotal trials, MIRVASO reduced the erythema of rosacea for up to 12 hours (22% vs 9%; P<.001) and began working in as little as 30 minutes on day 1 versus vehicle (28% vs 6%; P<.001).1,2
One application treated redness for up to 12 hours1
Primary endpoint: In two 4-week studies, MIRVASO demonstrated significant 2-grade improvement of erythema versus vehicle as measured by clinicians and patients at hours 3 (28% vs 10%), 6 (28% vs 9%), 9 (22% vs 10%), and 12 (22% vs 9%) on day 29.1,2
Onset of redness reduction was observed in as little as 30 minutes1
Secondary endpoint: In two 4-week studies, MIRVASO demonstrated a
MIRVASO: Clinically Evaluated for Up to 52 Weeks2
In a 52-week safety study, MIRVASO was demonstrated to be safe and effective.2 The most common adverse events (≥4% of study participants) for the entire study were flushing (10%), erythema (8%), rosacea (5%), nasopharyngitis (5%), skin burning sensation (4%), increased intraocular pressure (4%), and headache (4%).2 See the tolerability profile of MIRVASO
- Fowler J Jr, Jackson JM, Moore A, et al; Brimonidine Phase III Study Group. Efficacy and safety of once-daily brimonidine tartrate gel 0.5% for the treatment of moderate to severe facial erythema of rosacea: results of two randomized, double-blind, and vehicle-controlled pivotal studies. J Drugs Dermatol. 2013;12(6):650-656.
- Data on file. Galderma Laboratories, L.P.
Important Safety Information
Indication: MIRVASO® (brimonidine) topical gel, 0.33%* is an alpha adrenergic agonist indicated for the topical treatment of persistent (nontransient) facial erythema of rosacea in adults 18 years of age or older. Adverse Events: In clinical trials, the most common adverse reactions (≥1%) included erythema, flushing, skin burning sensation and contact dermatitis. Warnings/Precautions: MIRVASO Gel should be used with caution in patients with depression, cerebral or coronary insufficiency, Raynaud's phenomenon, orthostatic hypotension, thromboangiitis obliterans, scleroderma, or Sjögren’s syndrome. Alpha-2 adrenergic agents can lower blood pressure. MIRVASO Gel should be used with caution in patients with severe or unstable or uncontrolled cardiovascular disease. Serious adverse reactions following accidental ingestion of MIRVASO Gel by children have been reported. Keep MIRVASO Gel out of reach of children. Not for oral, ophthalmic, or intravaginal use.
You are encouraged to report negative side effects of prescription drugs to the FDA. Visit www.fda.gov/medwatch or call 1-800-FDA-1088.
*Each gram of gel contains 5 mg of brimonidine tartrate, equivalent to
†Composite success: Improvement on both the Clinician Erythema Assessment and Patient Self-Assessment.
‡Pooled data analysis from 2 phase 3 trials.
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