FDA Approves Rosacea Treatment.
MedPage Today (8/26, Petrochko) reports that the Food and Drug Administration has approved Galderma’s brimonidine alpha-2 adrenergic agonist, “the first topical treatment specifically indicated for the persistent facial erythema of rosacea.” The treatment works by constricting dilated facial blood vessels, and is effective for 12 hours.
Medscape (8/26, Brooks) reports that the 16 million Americans afflicted with rosacea will have access to brimonidine starting in September.
The FDA has approved the alpha-2 adrenergic agonist brimonidine (Mirvaso) to treat facial redness in adult rosacea patients, the drug's manufacturer announced.
The new indication makes Mirvaso 0.33% topical gel the first topical treatment specifically indicated for the persistent facial erythema of rosacea, according to a statement from Galderma.
The gel is applied once a day to the forehead, chin, nose, and cheeks, and remains effective for up to 12 hours. The drug is thought to constrict dilated facial blood vessels, which reduces the redness in rosacea.
Approval for the new indication was based on phase III trial data from 550 patients in two month-long studies, which found that adult participants who used brimonidine gel had significant improvement of facial redness compared with those who used a placebo preparation.
Common adverse reactions during the trials included erythema, flushing, a burning sensation, and contact dermatitis.
Patients with depression, cerebral or coronary insufficiency, Raynaud's phenomenon, orthostatic hypotension, thromboangiitis obliterans, scleroderma, or Sjogren's syndrome, as well as those with severe, unstable, or uncontrolled cardiovascular disease should use the drug with caution, the agency said.
The gel should be kept out of reach of children as accidental ingestion has resulted in serious adverse events.
The agent should not be taken orally, ophthalmically, or intravaginally.
Mirvaso is marketed by Galderma.