Breaking News: FDA Approves MIRVASO for the Facial Erythema of Rosacea

October 2, 2013
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Mirvaso (brimonidine) topical gel, 0.33%
Now FDA-Approved! Mirvaso® (brimonidine) Topical Gel, 0.33%* for the Facial Erythema of Rosacea
An effective and safe topical treatment for the persistent (nontransient) facial erythema of rosacea is now available.1,2 The introduction of MIRVASO represents a new treatment option for rosacea sufferers: Unlike other rosacea treatments, MIRVASO was specifically developed to treat the facial erythema associated with rosacea.1
  Baseline - 3 Hours - 6 Hours - 12 Hours  
  Baseline - 3 Hours - 6 Hours - 12 Hours  
  Study Participant #8076-001  
  Clinical trials with MIRVASO demonstrated significant erythema reduction that lasted for up to 12 hours2  
  See Before and After Photos  
In two 4-week, phase 3 clinical trials (N=553),
patients using MIRVASO experienced2:
Rapid redness reduction and sustained relief
Primary study endpoint: Significant 2-grade improvement of erythema vs vehicle over 12 hours as measured on day 29 (22% vs 9%; P<0.001)2,3
Secondary study endpoint: At 30 minutes on day 1, significant 1-grade improvement of erythema vs vehicle after the first application (28% vs 6%; P<0.001)2,3
Learn more about the efficacy of mirvaso LEARN MORE ABOUT THE EFFICACY OF MIRVASO
The safety of MIRVASO was evaluated in two 4-week, phase 3 trials and a
52-week, phase 3 long-term study.1,3‡
In the two 4-week trials, the most common adverse events reported by ≥1% of study participants treated with MIRVASO vs vehicle included erythema (4% vs 1%), flushing (3% vs 0%), skin burning sensation (2% vs 1%), and contact dermatitis (1% vs <1%).1
In the long-term study, the most common adverse events (≥4% of study participants) were flushing (10%), erythema (8%), rosacea (5%), nasopharyngitis (5%), skin burning sensation (4%), increased intraocular pressure (4%), and headache (4%).3
Read mirvaso full prescribing information READ MIRVASO FULL PRESCRIBING INFORMATION
We think you'll find MIRVASO an important addition
to your rosacea armamentarium.

Sincerely,
Galderma Laboratories, L.P.
Help your patients save on their prescription
* Each gram of gel contains 5 mg of brimonidine tartrate, equivalent to 3.3 mg of brimonidine free base.
The safety and efficacy of MIRVASO was evaluated in 2 identical, randomized, vehicle-controlled trials with 553 patients aged 18 years and older. Study participants were randomized 1:1 to receive either MIRVASO or vehicle gel once daily for 4 weeks. The primary endpoint for both studies was 2-grade composite success at hours 3, 6, 9, and 12 on day 29. The secondary endpoint was 1-grade composite success at 30 minutes on day 1. Composite success was defined as improvement on both the Clinician Erythema Assessment and Patient Self-Assessment.2
The long-term safety and efficacy of MIRVASO was studied in a 52-week, multicenter, open label, non-comparative study with 449 patients with moderate to severe facial erythema of rosacea. The primary objective of the study was to evaluate the long-term safety of MIRVASO applied once daily for up to 12 months. The secondary objective of the study was to evaluate the long-term efficacy of MIRVASO applied once daily for up to 12 months.3
1. MIRVASO Gel [prescribing information]. Galderma Laboratories, L.P.: Fort Worth, TX; 2013.
2. Fowler J Jr, Jackson JM, Moore A, et al; Brimonidine Phase III Study Group. Efficacy and safety of once-daily topical 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.
3. 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.