Journey Medical Corporation Announces FDA Approval of Emrosi™ for Rosacea Treatment

SCOTTSDALE, Ariz., Nov. 04, 2024 (GLOBE NEWSWIRE) -- Journey Medical Corporation (Nasdaq: DERM), a pharmaceutical company focused on dermatological treatments, has announced that the U.S. Food and Drug Administration (FDA) has approved Emrosi™ (Minocycline Hydrochloride Extended Release Capsules, 40 mg) for treating inflammatory lesions of rosacea in adults. Emrosi, previously known as DFD-29, was developed in collaboration with Dr. Reddy’s Laboratories Ltd.

Claude Maraoui, Co-Founder, President, and CEO of Journey Medical, expressed pride in delivering Emrosi to patients in the U.S. suffering from rosacea. He highlighted the challenges of treating this skin condition and emphasized the potential of Emrosi to become the leading oral treatment based on favorable Phase 3 clinical trial results. Maraoui stated that Journey Medical's dermatology-focused sales team is preparing for a successful launch, aiming to establish Emrosi as a new standard of care for rosacea. He reaffirmed the company's commitment to providing innovative treatments to patients with dermatological conditions and the healthcare professionals who treat them.

The FDA approval of Emrosi is based on positive data from two Phase 3 clinical trials conducted by Journey Medical for rosacea treatment. These trials met all primary and secondary endpoints, with subjects completing the 16-week treatment without significant safety issues. Emrosi showed statistically significant superiority over the current standard-of-care treatment, Oracea® 40 mg capsules, and placebo in reducing inflammatory lesions and achieving Investigator’s Global Assessment treatment success in both studies.

Journey Medical is finalizing the manufacturing of Emrosi for the U.S. market and expects the initial supply to be available late in the first quarter or early in the second quarter of 2025. The company plans to commercialize Emrosi in the U.S. with its dermatology-focused commercial organization and will implement a launch strategy to promote Emrosi as the new oral standard of care for adult rosacea patients.

Srinivas Sidgiddi, M.D., Vice President of Research & Development at Journey Medical, noted the efficacy and tolerability of Emrosi demonstrated in the pivotal clinical trials. He expressed gratitude to the patients, physicians, investigators, and site coordinators who contributed to this significant approval milestone.

Rosacea is a chronic, relapsing inflammatory skin condition characterized by symptoms such as deep facial redness, acne-like lesions, and spider veins. According to The National Rosacea Society, over 16 million Americans and approximately 415 million people worldwide are affected by rosacea, most commonly seen in adults between 30 and 50 years of age. Surveys indicate that more than 90 percent of rosacea patients report lowered self-confidence and self-esteem, and 41 percent avoid public contact or cancel social engagements due to their condition. Among patients with severe symptoms, 88 percent said the disorder adversely affected their professional interactions, and 51 percent missed work because of it.

Journey Medical Corporation, based in Scottsdale, Arizona, focuses on selling and marketing FDA-approved prescription pharmaceutical products for dermatological conditions. The company markets nine products, including seven branded and two generic products, to treat common skin conditions. Journey Medical was founded by Fortress Biotech, Inc. (Nasdaq: FBIO) and is a commercial-stage pharmaceutical company with a team of industry experts experienced in developing and commercializing successful dermatology prescription brands.