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New Rosacea Treatment Option Approved by FDA
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New Rosacea Treatment Option Approved by FDA

FDA has approved an antibiotic called minocycline to treat rosacea in adults. The oral drug will be available under the brand name Emrosi.

Rosacea affects approximately 16 million people in the United States and more than 400 million people worldwide; mostly adults between 30 and 50 years old. Symptoms often come and go with flares, including facial redness, pimple-like bumps, and visible small blood vessels (spider veins). ). The rash usually occurs on the nose, cheeks and forehead.

By reducing swelling and inflammation, Emrosi offers a new treatment option, especially for acne-like bumps. Each capsule contains 40 milligrams of minocycline, including 10 milligrams that are immediate-acting and 30 milligrams that are released slowly over time (called extended-release). This helps the medicine stay at a constant level in the body for longer and provides better results. This also means fewer daily doses and lower risk of side effects.

By Journey Medical Corporation, Dr. Manufactured in collaboration with Reddy’s Laboratories, Emrosi will be available as a once-daily oral capsule, with initial supplies expected in the United States in late 2024 or early 2025.

The approval was supported by results from two phase III clinical trials in which participants completed 16 weeks of treatment without significant safety concerns. These trials compared Emrosi with the current standard of care (40-milligram Oracea capsules) and placebo. The results showed that Emrosi was more effective than either of them at improving rosacea symptoms, especially reducing the number of red, swollen bumps.

Journey Medical, its Press releaseHe noted that the most common side effect is dyspepsia (indigestion), warning of serious allergic reactions, especially in people with allergies. tetracyclines (a class of antibiotics that treat bacterial infections such as acne).

People taking Emrosi are advised to limit their exposure to both natural and artificial sun; because this can cause darkening of various parts of the body, including the skin, nails, eyes and inside the mouth. Journey Medical also warns against the use of Emrosi during the second and third trimesters of pregnancy, as well as infancy and childhood through age 8, as it may cause permanent tooth staining and temporarily slow bone growth. Other warnings and side effects should be discussed with your healthcare provider before and during treatment.