Journey Rosacea Drug Approved by FDA

FDA has approved a Journey Medical NDA for Emrosi (minocycline hydrochloride extended release capsules, 40 mg) for treating inflammatory lesions of rosacea in adults. Approval is based on data from two Phase 3 clinical trials that met all co-primary and secondary endpoints, and subjects completed the 16-week treatment with no significant safety issues, according to the company. “Emrosi demonstrated statistically significant superiority over both the current standard-of-care treatment, Oracea 40 mg capsules, and placebo,” Journey says, adding that it showed a statistically significant reduction in total inflammatory lesion count in both studies.

Journey says that the most common adverse reaction reported with Emrosi and more frequently than in subjects receiving placebo was dyspepsia. The product labeling includes a contraindication in those who have a history of hypersensitivity to any tetracycline.