Journey Medical has received approval from the US Food and Drug Administration (FDA) approval for Emrosi (Minocycline Hydrochloride extended release Capsules, 40 mg) for the treatment of rosacea.
Formerly known as DFD-29, Emrosi is intended to treat inflammatory lesions caused by this chronic, relapsing, inflammatory skin condition in adults.
Journey Medical, which is a dermatological conditions-focused pharmaceutical firm based in Arizona, developed the drug in collaboration with Dr. Reddy’s Laboratories.
The new drug application (NDA) for DFD-29 was filed in January 2024 and was accepted in March 2024.
The FDA approval is backed by positive results from two Phase 3 clinical trials. These trials met all co-primary and secondary endpoints.
Subjects completed the 16-week treatment with no major safety concerns.
Emrosi showed statistically significant superiority over the current standard of care, Oracea 40 mg capsules and placebo.
It outperformed both treatments in the Investigator’s Global Assessment success and in reducing the total inflammatory lesion count in both trials.
Journey Medical co-founder, president, and CEO Claude Maraoui said: “With approval from the FDA, Journey Medical is proud to deliver Emrosi, a unique treatment option for the millions of patients in the US suffering from rosacea.
“Rosacea is a difficult to treat skin condition and based on the favourable 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.”
Journey Medical is in the process of finalising the manufacturing of Emrosi for the US market.
The pharmaceutical company expects the initial supply to become available by late Q1 or early Q2 of 2025.
Journey Medical plans to commercialise the drug in the US through its dermatology-focused sales team.
Following the approved label, the company will implement a launch strategy to position Emrosi as a new oral standard of care for adult rosacea patients.
Journey Medical focuses on selling and marketing FDA-approved prescription drugs for dermatological conditions.
The firm currently markets seven branded products and two generic treatments for common skin conditions.
