FDA Approves New Option for Rosacea

The FDA approved minocycline hydrochloride extended-release capsules (Emrosi) for treating inflammatory lesions of rosacea in adults, drugmaker Journey Medical announced on Monday.

Approval of the tetracycline antibiotic for this indication was supported by data from two multicenter phase III trials — MVOR-1 and MVOR-2 — involving 653 adults with papulopustular rosacea.

Participants were randomized to either daily minocycline hydrochloride (40 mg); doxycycline, the current standard of care; or placebo for 16 weeks. At baseline, participants had at least 15 papules or pustules (mean 25 inflammatory lesions) and an Investigator’s Global Assessment (IGA) score of 3 or 4, indicating moderate or severe disease.

At 16 weeks, a higher proportion of patients in the minocycline hydrochloride group achieved treatment success — an IGA of 0-1 (clear or near-clear) with at least a two-grade reduction from baseline — compared with the doxycycline and placebo groups:

• MVOR-1: 65% vs 46% and 31%, respectively
• MVOR-2: 60% vs 31% and 27%

In addition, the two trials showed significantly greater mean reductions in inflammatory lesion counts with minocycline hydrochloride (75-79%) versus both doxycycline (60-63%) or placebo (46-47%).

According to the prescribing information, dyspepsia was the most common adverse event in trials, occurring in 2% of patients versus none assigned to placebo. Given the potential risks for drug-resistant bacteria, minocycline hydrochloride should only be used as indicated.

The drug is contraindicated in patients with a history of hypersensitivity to tetracyclines. Cases of anaphylaxis, serious skin reactions, erythema multiforme, and drug rash with eosinophilia and systemic symptoms (DRESS) syndrome have been reported in patients using minocycline hydrochloride for acne. Use in pregnancy and in children can lead to permanent teeth discoloration and inhibit bone growth; breastfeeding during use is not recommended.

Labeling for the new formulation also includes warnings and precautions about Clostridioides difficile-associated diarrhea, hepatotoxicity, central nervous system effects, idiopathic intracranial hypertension, autoimmune syndromes, and metabolic effects.

Journey Medical said it expects the drug to be available in the first half of 2025.