The U.S. Food and Drug Administration (FDA) has granted approval to Journey Medical's Emrosi (Minocycline Hydrochloride extended-release Capsules, 40 mg) for the treatment of inflammatory lesions caused by rosacea in adult patients. This approval marks a significant advancement in the treatment of this chronic, relapsing inflammatory skin condition.
Developed in collaboration with Dr. Reddy’s Laboratories, Emrosi, formerly known as DFD-29, is poised to offer a new oral standard of care for the millions of Americans suffering from rosacea. The FDA's decision was supported by robust data from two Phase 3 clinical trials, which demonstrated Emrosi's superiority over existing treatments.
Phase 3 Clinical Trial Results
The two Phase 3 trials evaluated the efficacy and safety of Emrosi over a 16-week treatment period. The trials met all co-primary and secondary endpoints, with Emrosi showing statistically significant improvements compared to both placebo and Oracea 40 mg capsules, a current standard of care. Key findings included:
- Investigator’s Global Assessment (IGA) Success: Emrosi outperformed both Oracea and placebo in achieving IGA success, a measure of overall disease severity.
- Reduction in Inflammatory Lesions: Emrosi significantly reduced the total inflammatory lesion count compared to both treatments.
No major safety concerns were reported during the trials, underscoring the drug's favorable safety profile.
Commercialization and Availability
Journey Medical is currently finalizing the manufacturing process for Emrosi and anticipates that the initial supply will be available in the U.S. market by late Q1 or early Q2 of 2025. The company plans to commercialize Emrosi through its dedicated dermatology sales team, implementing a launch strategy designed to establish the drug as a new oral standard of care for adult rosacea patients.
Journey Medical's Commitment
Claude Maraoui, co-founder, president, and CEO of Journey Medical, expressed enthusiasm about the approval, stating, "With approval from the FDA, Journey Medical is proud to deliver Emrosi, a unique treatment option for the millions of patients in the US suffering from rosacea... Based on the favourable results from our Phase 3 clinical trials, Emrosi has potential to become the best-in-class oral medication to treat the condition."
Journey Medical focuses on selling and marketing FDA-approved prescription drugs for dermatological conditions. The firm currently markets seven branded products and two generic treatments for common skin conditions.
