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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
DFD-29 (40 mg Minocycline Hydrochloride Modified-Release Capsules, 10 mg immediate release and 30 mg extended release) achieved the co-primary and all
About this update from Fortress Biotech, Inc.
[{"type":"text","content":"DFD-29 (40 mg Minocycline Hydrochloride Modified-Release Capsules, 10 mg immediate release and 30 mg extended release) achieved the co-primary and all secondary endpoints with no significant safety issues when administered once daily for 16 weeks Published data from two Phase 3 clinical trials demonstrated statistical superiority of DFD-29 over both Oracea® (doxycycline) capsules and placebo for IGA treatment success and the reduction of total lesion count, as well as significantly superior reduction in erythema compared to placebo in both studies U.S. FDA approved Emrosi™ (also known as DFD-29) for the treatment of inflammatory lesions of rosacea in adults in November 2024; launch expected in early spring of 2025 SCOTTSDALE, Ariz., March 05, 2025 (GLOBE NEWSWIRE) -- Journey Medical Corporation (Nasdaq: DERM) (“Journey Medical”), a commercial-stage pharmaceutical company that primarily focuses on selling and marketing U.S. Food and Drug Administration (“FDA”)-approved prescription pharmaceutical products for the treatment of dermatological conditions, today announced that full results from two Phase 3 multicenter, randomized, double-blind, parallel-group, active-comparator and placebo-controlled clinical trials, Minocycline Versus Oracea® in Rosacea-1 (“MVOR-1”) and Minocycline Versus Oracea in Rosacea-2 (“MVOR-2”), evaluating Minocycline Hydrochloride Extended Release Capsules, 40 mg (“DFD-29” or “Emrosi”) for the treatment of moderate-to-severe papulopustular rosacea in adults were published in the Journal of the American Medical Association - Dermatology (“JAMA Dermatology”). The results demonstrated the efficacy, safety and tolerability of oral DFD-29 in rosacea. Read the full publication here: JAMA. The FDA approved Emrosi™ for the treatment of inflammatory lesions of rosacea in adults in November 2024. Claude Maraoui, Co-Founder, President and Chief Executive Officer of Journey Medical, stated, “Emrosi’s FDA approval last November, supported by these robust and clinically meaningful outcomes, positions it as a potential new treatment paradigm for millions of patients with rosacea. We are thrilled that the positive results of our two Phase 3 clinical trials were published in JAMA Dermatology. This milestone underscores the significance of these findings and reinforces Emrosi’s potential to meaningfully benefit patients when...