Journey Medical Corporation recently announced the FDA approval of Emrosi (Minocycline Hydrochloride Extended Release Capsules, 40 mg), formerly referred to as DFD-29, for the treatment of inflammatory lesions of rosacea in adults, which was developed in collaboration with Dr. Reddy’s Laboratories Ltd.
Claude Maraoui, Co-Founder, President, and Chief Executive Officer of Journey Medical, commented, “With approval from the FDA, Journey Medical is proud to deliver Emrosi, a unique treatment option for the millions of patients in the U.S. suffering from rosacea. Rosacea is a difficult to treat skin condition and based on the favorable results from our Phase 3 clinical trials, Emrosi has potential to become the best-in-class oral medication to treat the condition. Our seasoned dermatology-focused sales force is now preparing for a successful launch and to establish Emrosi as a new standard of care in the treatment of rosacea. Journey Medical is committed to bringing cutting-edge innovation to patients with dermatological conditions and the healthcare professionals who treat them.”
The recent FDA approval of Emrosi comes after the positive results obtained from Journey Medical’s two Phase 3 clinical trials for the treatment of rosacea. During the Phase 3 clinical trials no significant safety issues arrose after participants completed the 16-week treatment course, and all co-primary and secondary endpoints were met.
Researchers concluded in both studied that in comparison to the current standard treatment, Oracea 40 mg capsules, and placebo, Emrosi exhibited statistically significant superiority in achieving Investigator’s Global Assessment treatment success (IGA-TS) and reduction in total inflammatory lesion count. Journey Medical anticipates the initial supply of Emrosi for the U.S. market will be available by late first quarter or early second quarter of 2025, with the launch strategy intending to make Emrosi the new adult rosacea oral standard of care.
Srinivas Sidgiddi, M.D., Vice President, Research & Development at Journey Medical, added, “Emrosi showed great efficacy and tolerability in the pivotal clinical trials, and we are tremendously grateful to the patients, physicians, investigators, and site coordinators who participated and contributed to this important approval milestone.”
Reference:
1. "Journey Medical Corporation Announces U.S. FDA Approval of Emrosi™ (Minocycline Hydrochloride Extended Release Capsules, 40 mg) for the Treatment of Rosacea," SCOTTSDALE, Ariz., Nov. 04, 2024 (GLOBE NEWSWIRE)
