¡New FDA approval for rosacea!
Provides an oral alternative to previous treatments
November 06 2024
Rosacea: It is a chronic inflammatory skin condition, that affects more than 16 million Americans and about 415 million people worldwide. It commonly occurs in adults between 30 and 50 years of age with symptoms such as facial redness, acne-like inflammatory lesions, and visible veins on the face.
Impact on quality of life: More than 90% of patients report that rosacea affects their confidence and self-esteem, and 41% avoid social contact or cancel commitments due to their condition.
New treatment approved by the FDA: The FDA has approved Emrosi™ (Minocycline Hydrochloride Extended Release, 40 mg), developed in collaboration with Dr. Reddy’s Laboratories, for the treatment of inflammatory lesions of rosacea in adults.
Advantages of Emrosi: Journey Medical, the company behind Emrosi, notes that based on the favorable results of Phase 3 clinical trials, Emrosi could establish itself as a reference in the oral treatment of rosacea. The company is preparing its dermatology-focused sales team for a successful launch, and seeks to have Emrosi considered a new standard of care for this condition.
Clinical trial results: Emrosi Phase 3 clinical trials showed that this treatment was statistically superior to both the current standard of care (Oracea® 40 mg) and placebo. Emrosi achieved improved results in Investigator Global Assessment success and reduction in total inflammatory lesion count, completing a 16-week treatment without major safety issues.
This new treatment represents an innovative and potentially more effective alternative for patients suffering from rosacea, who will soon be able to access Emrosi on the market.