The U.S. Food and Drug Administration (FDA) has granted approval to Emrosi (minocycline hydrochloride) for the treatment of inflammatory lesions associated with rosacea in adult patients. Developed by Journey Medical Corporation, Emrosi is formulated as a 40 mg extended-release capsule designed to provide a steady delivery of minocycline, a tetracycline-class drug with anti-inflammatory properties. This approval marks a significant advancement in rosacea management, offering a new systemic therapy option that addresses both erythema and inflammatory lesions, key characteristics of the condition.
Clinical Trial Efficacy
The FDA's decision was supported by data from two Phase 3 clinical trials, MVOR-1 and MVOR-2, which evaluated the efficacy and safety of Emrosi. These trials met all co-primary and secondary endpoints, demonstrating statistically significant superiority over both the current standard-of-care treatment, Oracea (doxycycline 40 mg), and placebo. Key outcomes included Investigator’s Global Assessment (IGA) treatment success and a reduction in total inflammatory lesion count. The trials also reported minimal adverse events, with dyspepsia being the most common, occurring in a small percentage of patients.
Srinivas Sidgiddi, MD, vice president of research and development at Journey Medical, stated, "Emrosi showed great efficacy and tolerability in the pivotal clinical trials."
Mechanism of Action and Unique Formulation
Emrosi contains 40 mg of minocycline, comprising 10 mg of immediate-release and 30 mg of extended-release beads. This formulation is designed to mitigate fluctuations in drug levels, potentially reducing adverse effects and improving tolerability. Minocycline, a well-established tetracycline antibiotic, has demonstrated anti-inflammatory properties at lower, sub-antimicrobial doses, without exerting selection pressure for bacterial resistance.
Rosacea and Current Treatment Landscape
Rosacea is a chronic inflammatory skin condition characterized by facial redness, inflammatory lesions (papules and pustules), and telangiectasia (spider veins). The approval of Emrosi addresses a significant unmet need in rosacea treatment by providing a therapy that targets both inflammatory and vascular components of the condition. Prior to Emrosi, only a few drugs had received FDA approval for rosacea in the past decade, including topical treatments like ivermectin, oxymetazoline hydrochloride, minocycline foam, and benzoyl peroxide cream.
Market Launch and Future Implications
Journey Medical anticipates launching Emrosi in the first half of 2025. Claude Maraoui, the cofounder, president, and CEO of Journey Medical, expressed confidence that Emrosi has the potential to become the best-in-class oral medication to treat rosacea. The availability of Emrosi is expected to address the growing demand for comprehensive and patient-centered rosacea therapies, potentially simplifying treatment regimens for patients.
Safety Information
Warnings and precautions associated with Emrosi include serious skin/hypersensitivity reactions, potential tooth discoloration and reversible inhibition of bone growth if used during pregnancy and childhood, Clostridioides difficile-associated diarrhea, hepatotoxicity, central nervous system side effects, idiopathic intracranial hypertension, autoimmune syndromes, and metabolic effects. The most common adverse reaction reported in clinical trials was dyspepsia.
