Wednesday, 04 December 2013 16:36

Galderma Receives FDA Approval of Mirvaso®

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Galderma Laboratories, L.P. recently announced that the U.S. Food and Drug Administration (FDA) has approved Mirvaso® (brimonidine) topical gel, 0.33 percent for the topical treatment of the facial erythema (redness) of rosacea in adults 18 years of age or older. Applied once daily, Mirvaso gel works quickly to reduce the redness of rosacea and lasts up to 12 hours.

Mirvaso is a topical gel that may work by constricting the dilated facial blood vessels to reduce the redness of rosacea. Mirvaso gel can be applied in a pea-sized amount, once daily to each of the five regions of the face: the forehead, chin, nose and each cheek. The approval of Mirvaso gel was based on data collected from more than 550 clients enrolled in two Phase 3 clinical studies of a one-month duration. The results from both studies showed that adults who used Mirvaso gel demonstrated significantly greater improvement in the facial redness of rosacea than vehicle gel. In addition, a long-term study in which 276 subjects used Mirvaso gel for up to 12 months was also conducted.
Mirvaso gel is safe and well-tolerated. In controlled clinical trials, the most common adverse reactions with an incidence of greater than or equal to one percent included erythema, flushing, burning sensation, and contact dermatitis. In the long-term study, the most common adverse events (greater than or equal to four percent of subjects) included flushing (10 percent), erythema (eight percent), rosacea (five percent), nasopharyngitis (five percent), skin burning sensation (four percent), increased intraocular pressure (four percent), and headache (four percent).

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