News today that Galderma has succeeded in gaining FDA Approval for Mirvaso – the brand name chosen for the product that during development was known as Sansrosa, CD07805/47 and Col-118.
The Brimonidine Tartrate 0.33% Topical Gel is expected to be available as soon as next month.
Great news that approval has been granted after so many years of waiting for rosacea sufferers following the development of this product.
It has been a long road for rosacea sufferers who have been waiting for a treatment for the red face of rosacea.
Mirvaso Works Quickly and Lasts up to 12 Hours
FT. WORTH, Texas–(BUSINESS WIRE)–Galderma Laboratories, L.P. today announced that the U.S. Food and Drug Administration (FDA) has approved Mirvaso(brimonidine) topical gel, 0.33% for the topical treatment of the facial erythema (redness) of rosacea in adults 18 years of age or older. Applied once daily, Mirvaso works quickly to reduce the redness of rosacea and lasts up to 12 hours. Galderma expects Mirvaso to be available in pharmacies September 2013.
The approval of Mirvaso was based on data collected from more than 550 patients enrolled in two phase 3 clinical studies of one-month duration. The results from both studies showed that adults who used Mirvaso demonstrated significantly greater improvement in the facial redness of rosacea than vehicle gel. In addition, a long-term study in 276 subjects who used Mirvaso for up to 12-months was also conducted. Mirvaso is a topical gel that may work by constricting the dilated facial blood vessels to reduce the redness of rosacea. Mirvaso should 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.
Note the Safety Information
Important Safety Information – Mirvaso® Gel
Indication: Mirvaso® (brimonidine) topical gel, 0.33% is an alpha-2 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.