FDA Approves Journey Medical's Emrosi™ for Rosacea Treatment
Key Insights
Journey Medical's Emrosi (search)™ (minocycline hydrochloride extended-release capsules, 40 mg) has received FDA approval for treating inflammatory lesions of rosacea (search) in adults.
Phase 3 clinical trials demonstrated Emrosi (search)'s superiority over Oracea® and placebo in reducing inflammatory lesions and achieving Investigator's Global Assessment treatment success.
Journey Medical anticipates Emrosi (search)™ will be available in the U.S. market in late Q1 or early Q2 2025, with plans to establish it as a new standard of care.
Journey Medical Corporation (NASDAQ: DERM) has announced that the U.S. Food and Drug Administration (FDA) has approved Emrosi (search)™ (Minocycline Hydrochloride Extended Release Capsules, 40 mg) for the treatment of inflammatory lesions of rosacea (search) in adults. The drug, formerly known as DFD-29, was developed in collaboration with Dr. Reddy's Laboratories Ltd (search).
Claude Maraoui, Co-Founder, President, and Chief Executive Officer of Journey Medical, stated, "With approval from the FDA, Journey Medical is proud to deliver Emrosi (search), a unique treatment option for the millions of patients in the U.S. suffering from rosacea (search). 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."
Clinical Trial Data
The FDA's approval of Emrosi (search) is backed by positive data from two Phase 3 clinical trials. These trials met all co-primary and secondary endpoints, with subjects completing the 16-week treatment without significant safety issues. Emrosi demonstrated statistically significant superiority over both the current standard-of-care treatment, Oracea® 40 mg capsules, and placebo in Investigator's Global Assessment treatment success and reduction in total inflammatory lesion count in both studies.
Srinivas Sidgiddi, M.D., Vice President, Research & Development at Journey Medical, added, "Emrosi (search) 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."
Commercialization Plans
Journey Medical is finalizing the manufacturing of Emrosi (search) for the U.S. market and expects the initial supply to be available in late Q1 or early Q2 2025. The company plans to commercialize Emrosi in the U.S. with its dermatology-focused commercial organization, aiming to establish it as a new oral standard of care for adult rosacea (search) patients.
About Rosacea
Rosacea (search) is a chronic, relapsing, inflammatory skin condition characterized by symptoms such as deep facial redness, acne-like inflammatory lesions (papules and pustules), and spider veins (telangiectasia). The National Rosacea Society estimates that rosacea affects over 16 million Americans and as many as 415 million people worldwide. It is most frequently 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 due to their condition, with 41 percent avoiding public contact or canceling social engagements.
Safety Information
EMROSI (search)™ is indicated for the treatment of inflammatory lesions (papules and pustules) of rosacea (search) in adults. The most common adverse reaction reported by ≥1% of subjects treated with EMROSI and more frequently than in subjects receiving placebo was dyspepsia. EMROSI is contraindicated in patients with a history of hypersensitivity to any of the tetracyclines. Warnings and precautions include the potential for anaphylaxis, serious skin reactions, tooth discoloration, antibiotic-associated colitis, liver injury, and photosensitivity. Patients should minimize or avoid exposure to natural or artificial sunlight while using EMROSI. Because of the potential for drug-resistant bacteria to develop during the use of EMROSI, use EMROSI only as indicated. Periodic laboratory evaluations of organ systems, including hematopoietic, renal and hepatic studies, should be performed.