FDA Approves Journey Medical’s Rosacea Medication Emrosi

On November 4, Journey Medical announced that the FDA has approved Emrosi? (extended-release minocycline hydrochloride capsules, 40 mg) for the treatment of inflammatory lesions in adult rosacea.

This approval is supported by positive data from two Phase III clinical studies. Subjects completed a 16-week treatment course with no significant safety issues. In both studies, Emrosi showed superior results over current standard treatment options, such as Oracea capsules and a placebo, in terms of treatment success rate in the "Investigator's Global Assessment" as well as a reduction in the total number of inflammatory lesions. 

Emrosi was developed through a collaboration between Journey Medical and Dr. Reddy’s Laboratories. Journey Medical is finalizing the production of Emrosi for the U.S. market and expects to begin supply in late Q1 or early Q2 of 2025. Journey Medical plans to commercialize Emrosi in the U.S. through a dedicated dermatology-focused sales team. Based on the approved indication, Journey Medical aims to establish Emrosi as a new oral treatment standard for adult rosacea patients. 

Journey Medical's Co-Founder, President, and CEO, Claude Maraoui, stated: "With FDA approval, Journey Medical is honored to provide a unique treatment option for millions of Americans with rosacea. Rosacea is a challenging skin condition, and based on our promising Phase III clinical trial results, Emrosi has the potential to become the leading oral medication for treating rosacea. Our experienced, dermatology-focused sales team is preparing for a successful launch, striving to make Emrosi the new standard in rosacea treatment. Journey Medical is committed to bringing cutting-edge innovations to patients with skin diseases and the healthcare providers who treat them."