Journey Medical Corporation (Nasdaq: DERM) has 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 in adults. This approval marks a significant milestone for the company and offers a new treatment option for the millions of Americans affected by this chronic skin condition.
Emrosi, formerly known as DFD-29, was developed in collaboration with Dr. Reddy’s Laboratories Ltd. The FDA's decision was supported by data from two Phase 3 clinical trials, both of which met all co-primary and secondary endpoints. These trials demonstrated Emrosi's statistically significant superiority over both the current standard-of-care treatment, Oracea 40 mg capsules, and placebo.
Clinical Trial Results
The Phase 3 trials evaluated the efficacy and safety of Emrosi over a 16-week treatment period. The co-primary endpoints included Investigator’s Global Assessment treatment success (IGA-TS) and the reduction in total inflammatory lesion count. Results indicated that Emrosi was significantly more effective than both Oracea and placebo in achieving IGA-TS and reducing inflammatory lesions. No significant safety issues were reported during the trials.
Srinivas Sidgiddi, M.D., Vice President, 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."
Commercialization Strategy
Journey Medical is currently 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 plans to commercialize Emrosi in the U.S. through its dermatology-focused commercial organization, with a launch strategy aimed at establishing Emrosi as a new oral standard of care for adult rosacea patients.
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. Rosacea is a difficult to treat skin condition and based on the favorable 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."
About Rosacea
Rosacea is a chronic inflammatory skin condition affecting over 16 million Americans and as many as 415 million people worldwide. It commonly presents with symptoms such as facial redness, acne-like inflammatory lesions (papules and pustules), and spider veins (telangiectasia). The condition primarily affects adults between 30 and 50 years of age and can significantly impact self-confidence and social interactions.
Important Safety Information
EMROSI is indicated for the treatment of inflammatory lesions (papules and pustules) of rosacea 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 should not be taken by patients who have a history of hypersensitivity to any of the tetracyclines. Cases of anaphylaxis, serious skin reactions (e.g., Stevens-Johnson syndrome), erythema multiforme, and drug rash with eosinophilia and systemic symptoms (DRESS) syndrome have been reported postmarketing with minocycline use in patients with acne. If DRESS syndrome is recognized, discontinue EMROSI immediately. Use 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. Discontinue EMROSI use if Antibiotic-Associated Colitis occurs. Discontinue EMROSI if liver injury is suspected. Patients experiencing light-headedness, dizziness or vertigo should be cautioned about driving vehicles or operating heavy machinery. Clinical manifestations include headache, blurred vision, diplopia, and vision loss. Discontinue EMROSI immediately if symptoms occur. Symptoms may be manifested by fever, rash, arthralgia, and malaise. Discontinue EMROSI immediately if symptoms occur. Patients should minimize or avoid exposure to natural or artificial sunlight while using EMROSI. Tetracycline-class antibiotics are known to cause hyperpigmentation. EMROSI may induce hyperpigmentation in many organs, including nails, bone, skin, eyes, thyroid, visceral tissue, oral cavity, sclerae and heart valves. 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. Perform periodic laboratory evaluations of organ systems, including hematopoietic, renal and hepatic studies.
