The FDA has approved an antibiotic called minocycline for the treatment of rosacea in adults. The drug, which is taken orally, will be sold under the brand name Emrosi.
Rosacea affects about 16 million people in the United States and over 400 million worldwide – mostly adults ages 30 to 50. Symptoms often come and go, with flare-ups involving facial redness, pimple-like bumps, and small visible blood vessels (spider veins). Redness generally occurs on the nose, cheeks, and forehead.
Emrosi offers a new treatment option, mainly for the pimple-like bumps, by reducing swelling and inflammation. Each capsule contains 40 milligrams of minocycline, including 10 milligrams that work immediately and 30 milligrams that are released slowly over time (called extended release). This helps maintain a steady level of the drug in the body over a longer duration and provides better results. It also means fewer daily doses and a lower risk for side effects.
Emrosi, made by Journey Medical Corporation in collaboration with Dr. Reddy's Laboratories, will be available as a once-daily oral capsule, with initial supplies in the United States expected by late 2024 or early 2025.
The approval was backed by results from two phase III clinical trials in which participants completed a 16-week treatment without major safety concerns. These trials compared Emrosi with the current standard of care (40-milligram capsules of Oracea) and with a placebo. Results showed that Emrosi was more effective than both at improving symptoms of rosacea, especially in reducing the number of red, swollen bumps.
Journey Medical, in their press release, stated that indigestion (dyspepsia) is the most common side effect and warned about serious allergic reactions, particularly in people who are sensitive to tetracyclines (a class of antibiotics that treat bacterial infections such as acne).
People taking Emrosi are advised to limit sun exposure, both natural and artificial, as it may cause darkening of various body parts, including the skin, nails, eyes, and inside of the mouth. Journey Medical also warned against using Emrosi during the second and third trimesters of pregnancy, as well as in infancy and childhood up to age 8, as it can cause permanent tooth staining and temporarily slow bone growth. Other warnings and side effects should be discussed with your health care provider before and during treatment.
