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Journey Medical Corporation Announces Publication in the Journal of the American Medical Association - Dermatology of the Phase 3 Clinical Trial Results of Emrosi™ (DFD-29) to Treat Rosacea
Journey Medical Journey Medical (US:DERM) Newsfilter·2025-03-05 21:01

Core Insights - Emrosi™ (DFD-29) received FDA approval for treating inflammatory lesions of rosacea in adults in November 2024, with a launch expected in early spring 2025 [2][3] - The results from two Phase 3 clinical trials (MVOR-1 and MVOR-2) demonstrated the efficacy and safety of DFD-29, showing statistical superiority over Oracea® (doxycycline) and placebo [1][3] Company Overview - Journey Medical Corporation is a commercial-stage pharmaceutical company focused on marketing FDA-approved prescription products for dermatological conditions [11] - The company is based in Scottsdale, Arizona, and was founded by Fortress Biotech, Inc. [11] Clinical Trial Results - In MVOR-1, 65.0% of subjects in the DFD-29 group achieved IGA success compared to 46.1% in the Oracea group and 31.2% in the placebo group, with significant p-values of 0.01 and <0.001 respectively [4][6] - In MVOR-2, 60.1% of subjects in the DFD-29 group achieved IGA success compared to 31.4% in the Oracea group and 26.8% in the placebo group, with significant p-values of <0.001 for both comparisons [5][6] - DFD-29 showed a mean reduction of 21.3 lesions in MVOR-1 and 18.0 lesions in MVOR-2, both statistically significant compared to Oracea and placebo [4][5][6] Safety Profile - No major safety issues or serious adverse events were reported in both clinical trials, with treatment-emergent adverse events being similar across groups [3][4][5] Market Potential - Rosacea affects over 16 million Americans and approximately 415 million people worldwide, indicating a significant market opportunity for Emrosi™ [9][10]