FDA Approves Emrosi for Rosacea

Key Takeaways

• The FDA has approved Emrosi^™ for treating inflammatory lesions of rosacea in adults.
• Emrosi outperformed Oracea^® and placebo, showing significant efficacy and tolerability, clincial research suggests.
• Journey Medical plans to launch Emrosi in early 2025.

The US Food and Drug Administration (FDA) has approved Emrosi^™ (Minocycline Hydrochloride Extended Release Capsules, 40 mg) as a treatment for inflammatory lesions of rosacea in adults.

According to a press release from the manufacturer, Journey Medical (in partnership with Dr. Reddy’s Laboratories), Emrosi met all primary and secondary endpoints in two Phase 3 clinical trials. The trials were conducted over a 16-week study period. The results indicated Emrosi’s efficacy compared to Oracea® 40 mg capsules and a placebo (the results reached statistical significance). According to the news release, patients experienced a marked reduction in inflammatory lesion counts and achieved higher rates of Investigator’s Global Assessment treatment success. The treatment was well-tolerated with no safety signals. 

“With approval from the FDA, Journey Medical is proud to deliver Emrosi, a unique treatment option for the millions of patients in the U.S. suffering from rosacea," Journey Medical CEO Claude Maraoui said in a press release. The company plans to launch Emrosi in the first half of 2025.

Dr. Srinivas Sidgiddi, VP of Research & Development, praised the collaboration of all parties involved in the process: “We are tremendously grateful to the patients, physicians, investigators, and site coordinators who participated and contributed to this important approval milestone.”

Source: Journey Medical press release. November 4, 2024.