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Journey Medical Corporation Announces Emrosi™ Data Analysis to be Presented at the Society of Dermatology Physician Associates (SDPA) 2025 Annual Summer Dermatology Conference
Emrosi™ (DFD-29; 40 mg Minocycline Hydrochloride Modified-Release Capsules, 10 mg immediate release and 30 mg extended release) demonstrated efficacy
About this update from Fortress Biotech, Inc.
[{"type":"text","content":"Emrosi™ (DFD-29; 40 mg Minocycline Hydrochloride Modified-Release Capsules, 10 mg immediate release and 30 mg extended release) demonstrated efficacy independent of body weight differences when treating rosacea\nSCOTTSDALE, Ariz., June 20, 2025 (GLOBE NEWSWIRE) -- Journey Medical Corporation (Nasdaq: DERM) (“Journey Medical” or “the Company”, “we”, or “our”), 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 a data analysis from two Phase 3 multicenter clinical trials, evaluating Emrosi™ for the treatment of moderate-to-severe papulopustular rosacea in adults will be presented at the Society of Dermatology Physician Associates (SDPA) 2025 Summer Dermatology Conference taking place June 25-29 in Washington, DC. The analysis determined that differences in body weight did not affect the efficacy of Emrosi in the two Phase 3 trials, which supported its November 2024 FDA approval. “This analysis demonstrated that Emrosi is body weight independent, which means it can be prescribed without regard to the patient's body weight. This is an important attribute, as it avoids the potential for errors in dose calculations,” said Julie Harper, MD, past president of the American Acne & Rosacea society (AARS) and Owner of the Dermatology and Skin Care Center of Birmingham, AL. “If doses were to be calculated based on body weight, the wide range of body weights in the real world would pose a challenge.” Subjects in the double-blind, placebo-controlled Minocycline Versus Oracea® in Rosacea-1 (“MVOR-1”) and Minocycline Versus Oracea in Rosacea-2 (“MVOR-2”) Phase 3 clinical trials were randomized in a 3:3:2 ratio to treatment with Emrosi, doxycycline 40 mg, or placebo once daily for 16 weeks. The coprimary efficacy endpoints were: 1) the proportion of participants demonstrating Investigator’s Global Assessment (“IGA”) treatment success with Emrosi vs. placebo; and 2) reductions in total inflammatory lesion counts with Emrosi vs. placebo. Comparisons between Emrosi and doxycycline were secondary endpoints. Sub-group analyses were conducted in patients with body weight less than or equal to the median body weight (≤MBW) and in patients with body weight great...