2024-11-06
On November 4, Journey Medical announced that the FDA has approved Emrosi™ (Minocycline hydrochloride sustained release capsule, 40mg) for the treatment of inflammatory lesions in adults with rosacea.
The approval is supported by positive data from two Phase III clinical studies. The subjects completed the 16-week treatment with no significant safety concerns. In both studies, Emrosi significantly outperformed the current standard of treatment, Orace capsules, and placebo, in the Investigator's Global Assessment of treatment success and reduction in the total number of inflammatory lesions.