Derma drug specialist Journey Medical Corporation announced that the FDA has approved its minocycline hydrochloride capsules, co-developed with Dr. Reddy’s, for the treatment of inflammatory lesions of rosacea in adults.
Branded Emrosi, the extended release 40 mg antibiotic capsules offer an alternative treatment option for the millions of patients in the U.S. suffering from rosacea. Rosacea is a chronic inflammatory skin condition that commonly presents with symptoms such as deep facial redness, acne-like inflammatory lesions and spider veins.
In two phase 3 trials, Emrosi demonstrated statistically significant superiority over both the current standard-of-care treatment, Galderma's Oracea (doxycycline) capsules, and placebo for Investigator’s Global Assessment treatment success as well as the reduction in total inflammatory lesion count. The IGA is a composite five-grade score used in clinical trials for rosacea, which includes the evaluation of reduction in erythema (redness) as well as reduction in inflammatory lesions.
Journey Medical is completing the manufacturing of Emrosi for the U.S. market and anticipates that initial supply will be available late in the first quarter or early in the second quarter of 2025.