Journey Medical’s Emrosi Receives FDA Approval, Setting New Standard for Rosacea Treatment

FDA Approval:
The U.S. Food and Drug Administration (FDA) has approved Journey Medical's Emrosi (minocycline hydrochloride extended release capsules, 40 mg) for the treatment of erythema and inflammatory lesions in adult patients with rosacea.

Clinical Trials:
The approval is based on positive data from two Phase 3 clinical trials, MVOR-1 and MVOR-2, which demonstrated statistical significance in reducing inflammatory lesions and erythema compared to placebo and the current standard-of-care treatment, Oracea.

New Standard of Care:
Emrosi is the only oral, systemic therapy approved to address both erythema and inflammatory lesions associated with rosacea, positioning it as a best-in-class therapeutic option.

Availability:
Journey Medical anticipates that Emrosi will be available in the U.S. market in the first half of 2025.

Market Impact:
The approval of Emrosi could shift the treatment landscape for rosacea, potentially challenging the dominance of Galderma in the rosacea market.

Company Background:
Journey Medical Corporation is a commercial-stage pharmaceutical company focused on developing and marketing FDA-approved prescription pharmaceutical products for dermatological conditions.