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. The 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.
Clinical Trial Success
The FDA's decision was supported by data from two Phase 3 clinical trials. These trials met all co-primary and secondary endpoints, demonstrating Emrosi's statistically significant superiority over both Oracea® 40 mg capsules (a current standard-of-care) and placebo. Key findings included:
- Significant reduction in total inflammatory lesion count.
- Higher Investigator's Global Assessment treatment success rates.
- No significant safety issues reported during the 16-week treatment period.
Srinivas Sidgiddi, M.D., Vice President, Research & Development at Journey Medical, expressed gratitude to the patients, physicians, investigators, and site coordinators who contributed to this important approval milestone, highlighting the drug's efficacy and tolerability in the pivotal clinical trials.
Commercialization and Availability
Journey Medical is finalizing the manufacturing of Emrosi for the U.S. market and anticipates initial supply to be available in late first quarter or early in the second quarter of 2025. The company plans to commercialize Emrosi using its established dermatology-focused commercial organization, aiming to establish it as a new oral standard of care for adult rosacea patients.
Addressing Rosacea
Rosacea is a chronic inflammatory skin condition characterized by facial redness, 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, predominantly adults between 30 and 50 years of age. The condition can significantly impact patients' quality of life, with over 90% reporting lowered self-confidence and self-esteem, and many avoiding public contact or social engagements.
Management Commentary
Claude Maraoui, Co-Founder, President, and Chief Executive Officer of Journey Medical, stated, "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... Emrosi has potential to become the best-in-class oral medication to treat the condition."
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 is contraindicated in patients with a history of hypersensitivity to any of the tetracyclines. Cases of anaphylaxis, serious skin reactions, and drug rash with eosinophilia and systemic symptoms (DRESS) syndrome have been reported postmarketing with minocycline use. The prescribing information includes warnings and precautions regarding potential risks such as tooth discoloration, antibiotic-associated colitis, liver injury, and photosensitivity. Patients should minimize or avoid exposure to natural or artificial sunlight while using Emrosi.
