The U.S. Food and Drug Administration (FDA) has approved Emrosi, an extended-release formulation of minocycline hydrochloride, as a new oral treatment for inflammatory rosacea in adults. With the approval, Emrosi (40 mg) is anticipated to be available by late Q1 or early Q2 of 2025, marking a significant advancement in rosacea care.

The FDA’s decision followed two successful 16-week phase 3 clinical trials that demonstrated Emrosi's effectiveness. The medication achieved all primary and secondary endpoints, showing a clear advantage over both Oracea (the current standard treatment) and a placebo. Patients using Emrosi saw a substantial reduction in inflammatory lesions and improved Investigator’s Global Assessment scores. Importantly, the trials revealed no significant safety concerns, supporting Emrosi’s suitability for long-term use.

"Rosacea is a challenging condition to manage, and based on the positive outcomes from our phase 3 trials, we believe Emrosi has the potential to become the best-in-class oral medication for this condition," said Claude Maraoui, cofounder, president, and CEO of Journey Medical. Maraoui also highlighted the company’s dermatology-focused sales team, which is gearing up to introduce Emrosi as a new standard in rosacea care.

The FDA approval represents a notable milestone for Journey Medical, adding to their dermatology portfolio and offering new hope to adults with inflammatory rosacea who may benefit from this innovative treatment option.