New Hope for Rosacea Sufferers: Emrosi Launched in the USA

On March 24, Journey Medical announced the launch of Emrosi (Minocycline hydrochloride extended-release capsules, 40 mg) in the United States. This groundbreaking medication has been approved for the treatment of inflammatory lesions associated with rosacea in adults.

Understanding Rosacea

Rosacea, commonly referred to as acne rosacea, is a frequent inflammatory skin condition. It’s characterized by deep red facial discoloration, acne-like lesions (such as papules and pustules), and spider veins (telangiectasia). Many adults struggle with this chronic, relapsing condition that can significantly impact their quality of life.

Emrosi: A Revolutionary Treatment

Emrosi is the first and only oral minocycline approved by the FDA specifically for treating inflammatory lesions of rosacea, addressing an important gap in dermatological care. The approval of Emrosi is founded on robust data from two pivotal phase 3 clinical trials, known as MVOR-1 (NCT05296629) and MVOR-2 (NCT05343455), which evaluated its safety and efficacy.

The Clinical Trials

In these 16-week multicenter, randomized, double-blind, active-controlled, and placebo-controlled trials, a total of 653 patients with papulopustular rosacea were assigned in a 3:3:2 ratio to receive Emrosi, 40 mg Oracea (doxycycline capsules), or placebo. The treatment duration lasted for 16 weeks, with an initial average inflammatory lesion count of 25 (ranging from 15 to 58). At the start, 88% of participants had moderate symptoms (IGA=3), while 12% presented with severe symptoms (IGA=4).

Key Outcomes of the Trials

The primary efficacy endpoints were the proportion of patients achieving an ” Investigator’s Global Assessment” (IGA) treatment success score of 0 (cleared skin) or 1 (almost cleared skin) on Week 16, and the absolute change in total inflammatory lesion count from baseline. Treatment success required at least a two-point reduction from baseline.

The results from both trials were promising. Emrosi demonstrated statistically significant superiority over the current standard treatment, doxycycline capsules, and placebo, in both IGA treatment success rates and the reduction in total inflammatory lesion counts.

Highlights from MVOR Trials

• MVOR-1: 65% of patients in the Emrosi group (n=122) achieved IGA treatment success, compared to 46% in the doxycycline group (n=121) and 31% in the placebo group (n=80). The Emrosi group saw an average absolute decrease of 20.6 lesions.
• MVOR-2: 60% of patients in the Emrosi group (n=123) achieved IGA treatment success. In comparison, the doxycycline group (n=125) achieved 31%, and the placebo group (n=82) achieved 27%. The Emrosi group showed an average absolute decrease of 18.1 inflammatory lesions.

Dosage and Administration

The recommended dosage for Emrosi is one capsule taken once daily. It can be taken with or without food, although taking it with food may help reduce the risk of esophageal irritation and ulcers.

Conclusion

With the introduction of Emrosi, patients suffering from rosacea now have a new and effective treatment option. This drug not only addresses a prevalent skin condition but also signifies progress in dermatological medicine. If you’re battling rosacea, discuss with your healthcare provider about whether Emrosi might be right for you! 🌟