FDA Approves Emrosi (Minocycline Hydrochloride) for Rosacea Treatment
Key Insights
The FDA has approved Emrosi (minocycline hydrochloride) for treating inflammatory lesions of rosacea (search) in adults, offering a new treatment option.
Phase 3 clinical trials demonstrated Emrosi's superiority over Oracea and placebo in reducing inflammatory lesions and achieving Investigator's Global Assessment treatment success.
Journey Medical anticipates Emrosi will be available in the U.S. market in late Q1 or early Q2 2025, with commercialization efforts focused on establishing it as a new standard of care.
Journey Medical Corporation (Nasdaq: DERM) announced that the U.S. Food and Drug Administration (FDA) has approved Emrosi™ (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 that Emrosi represents a unique treatment option for millions of rosacea (search) patients in the U.S. He expressed confidence that the drug has the potential to become the best-in-class oral medication for treating rosacea, based on favorable Phase 3 clinical trial results.
Clinical Trial Data
The FDA's approval of Emrosi was supported 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 Oracea® 40 mg capsules (a current standard-of-care treatment) and placebo. The superiority was measured by Investigator’s Global Assessment treatment success and the reduction in total inflammatory lesion count in both studies.
Srinivas Sidgiddi, M.D., Vice President, Research & Development at Journey Medical, highlighted the efficacy and tolerability of Emrosi in the pivotal clinical trials.
Launch and Commercialization
Journey Medical is finalizing the manufacturing of Emrosi for the U.S. market and anticipates that the initial supply will be available in late Q1 or early Q2 2025. The company intends 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.
Safety Information
Emrosi 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 tetracyclines.
Warnings and precautions include the potential for anaphylaxis, serious skin reactions (e.g., Stevens-Johnson syndrome), erythema multiforme, and drug rash with eosinophilia and systemic symptoms (DRESS) syndrome. The use of Emrosi during the second and third trimesters of pregnancy, infancy, and childhood up to the age of 8 years may cause permanent discoloration of the teeth and reversible inhibition of bone growth. The label advises discontinuing Emrosi if Antibiotic-Associated Colitis or liver injury occurs. Patients experiencing light-headedness, dizziness, or vertigo should be cautioned about driving vehicles or operating heavy machinery. Patients should minimize or avoid exposure to natural or artificial sunlight while using Emrosi. Tetracycline-class antibiotics are known to cause hyperpigmentation. Because of the potential for drug-resistant bacteria to develop during the use of Emrosi, use Emrosi only as indicated. If superinfection occurs, discontinue Emrosi and institute appropriate therapy. Periodic laboratory evaluations of organ systems, including hematopoietic, renal, and hepatic studies, should be performed.
Rosacea Overview
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 most frequently affects adults between 30 and 50 years of age. Surveys indicate that rosacea can significantly lower self-confidence and self-esteem, leading to social avoidance and impacting professional interactions.