FDA Approves Minocycline Hydrochloride (Emrosi) for Rosacea
Key Insights
The FDA has approved minocycline hydrochloride extended-release capsules (Emrosi) for treating inflammatory lesions of rosacea (search) in adults.
Phase III trials (MVOR-1 and MVOR-2) demonstrated that minocycline hydrochloride achieved significantly greater treatment success compared to doxycycline and placebo.
Minocycline hydrochloride showed superior mean reductions in inflammatory lesion counts compared to doxycycline and placebo in clinical trials.
The FDA has approved minocycline hydrochloride extended-release capsules (Emrosi) for the treatment of inflammatory lesions associated with rosacea (search) in adults. This announcement was made by Journey Medical, marking a new therapeutic option for a common and often distressing skin condition.
The approval is based on data from two Phase III multicenter trials, MVOR-1 and MVOR-2, which included a total of 653 adult participants with papulopustular rosacea (search). These trials compared the efficacy of daily minocycline hydrochloride (40 mg) to doxycycline, a current standard of care, and placebo over a 16-week period. Participants had at least 15 papules or pustules at baseline, with a mean of 25 inflammatory lesions, and an Investigator's Global Assessment (IGA) score of 3 or 4, indicating moderate to severe disease.
Efficacy Results
At the conclusion of the 16-week treatment period, a significantly higher proportion of patients treated with minocycline hydrochloride achieved treatment success, defined as an IGA score of 0-1 (clear or near-clear) with at least a two-grade reduction from baseline. Specifically, the results were:
- MVOR-1: 65% in the minocycline hydrochloride group versus 46% in the doxycycline group and 31% in the placebo group.
- MVOR-2: 60% in the minocycline hydrochloride group versus 31% in the doxycycline group and 27% in the placebo group.
Furthermore, the trials demonstrated that minocycline hydrochloride led to significantly greater mean reductions in inflammatory lesion counts (75-79%) compared to doxycycline (60-63%) and placebo (46-47%).
Safety and Warnings
The most common adverse event reported in the trials was dyspepsia, occurring in 2% of patients treated with minocycline hydrochloride compared to none in the placebo group. The prescribing information emphasizes that, due to the potential for developing drug-resistant bacteria, minocycline hydrochloride should only be used as indicated.
The drug is contraindicated in patients with a history of hypersensitivity to tetracyclines. Labeling includes warnings and precautions about Clostridioides difficile-associated diarrhea, hepatotoxicity, central nervous system effects, idiopathic intracranial hypertension, autoimmune syndromes, and metabolic effects. The use of minocycline hydrochloride during pregnancy and in children can lead to permanent teeth discoloration and inhibit bone growth, and breastfeeding is not recommended during use.
Availability
Journey Medical anticipates that Emrosi will be available in the first half of 2025. This new formulation offers a valuable addition to the treatment options available for individuals suffering from rosacea (search).