FDA Approves Emrosi (Minocycline) for Rosacea Treatment
Key Insights
The FDA has approved Emrosi (minocycline hydrochloride extended-release capsules 40 mg) for treating rosacea (search) in adults, offering a new therapeutic option.
Phase 3 trials demonstrated Emrosi's superiority over placebo and Oracea (doxycycline) in improving IGA scores and reducing inflammatory lesions after 16 weeks.
Developed by Journey Medical in collaboration with Dr. Reddy’s Laboratories, Emrosi is expected to be available in the U.S. market in early 2025.
The FDA has approved Emrosi (minocycline hydrochloride extended-release capsules 40 mg) for the treatment of rosacea (search) in adults, Journey Medical Corporation announced. This approval marks a significant advancement in the therapeutic options available for the millions of rosacea patients who may not find sufficient relief from current treatments.
Claude Maraoui, co-founder, president, and CEO of Journey Medical, stated that Emrosi offers a "new and compelling option" for physicians, supported by the superior results demonstrated in clinical trials.
Clinical Trial Data
The approval of Emrosi was based on data from two Phase 3 clinical trials. These trials demonstrated Emrosi's superiority over both placebo and Oracea (doxycycline 40 mg capsules), a current standard of care. After 16 weeks of treatment, patients treated with Emrosi showed greater improvements in Investigator's Global Assessment (IGA) scores and greater reductions in total inflammatory lesion counts compared to those treated with placebo and Oracea.
Expert Commentary
Andrew Huff, president and executive director of the National Rosacea (search) Society, welcomed the approval of Emrosi, noting that it "adds another arrow to the quiver for physicians targeting their patients’ papulopustular rosacea." He also highlighted that Emrosi's narrow spectrum of antibiotic activity may be particularly appealing to patients concerned about antibiotic resistance.
Development and Availability
Emrosi, previously known as DFD-29, was developed in collaboration with Dr. Reddy’s Laboratories. Journey Medical is currently finalizing the manufacturing process and anticipates launching Emrosi in the U.S. market in the first or early second quarter of 2025.
Rosacea and Current Treatments
Rosacea (search) is a chronic inflammatory skin condition affecting millions of adults. Current treatments often include topical and oral antibiotics, as well as other therapies to manage symptoms such as redness, bumps, and visible blood vessels. The introduction of Emrosi provides an additional option for physicians to tailor treatment plans to individual patient needs.