The U.S. Food and Drug Administration (FDA) has approved Journey Medical Corporation's Emrosi (minocycline hydrochloride extended-release capsules, 40 mg) for the treatment of erythema and inflammatory lesions in adult patients with rosacea. This approval marks a significant advancement in rosacea treatment, offering a new systemic option that addresses both key symptoms of the condition.
The approval is based on data from two Phase 3 clinical trials, MVOR-1 (NCT05296629) and MVOR-2 (NCT05343455), which met their primary and secondary endpoints. The trials demonstrated that Emrosi achieved statistical significance in Investigator's Global Assessment treatment success, reduction in the total number of inflammatory lesions, and reduction in Clinician's Erythema Assessment.
Clinical Trial Results
Participants in the 16-week trials experienced no significant adverse effects, with dyspepsia being the most common adverse event, reported by ≥ 1% of patients treated with Emrosi. Notably, Emrosi outperformed both placebo and doxycycline 40 mg tablets (Oracea) in these trials.
Srinivas Sidgiddi, MD, Vice President of Research & Development at Journey Medical, stated, "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."
Addressing Unmet Needs in Rosacea Treatment
Rosacea is a common skin condition characterized by facial erythema, inflammatory lesions (papules and pustules), and, in some cases, ocular manifestations. Current treatments often include topical therapies and oral antibiotics, but a need remains for treatments that effectively target both erythema and inflammatory lesions. Emrosi, with its demonstrated efficacy in addressing both aspects of the disease, fills this gap.
Dosing and Availability
Each Emrosi extended-release capsule contains 40 mg of minocycline, formulated as 10 mg immediate-release and 30 mg extended-release beads. The recommended dosage is one capsule daily, with or without food. Journey Medical anticipates that Emrosi will be available in late Q1 or early Q2 2025.
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... Emrosi has potential to become the best-in-class oral medication to treat the condition."
