James Del Rosso, DO, provides an overview of Emrosi for inflammatory lesions of rosacea, including clinical trial outcomes, safety, dosing, and more. 

Journey Medical Corporation has announced US FDA has approval of Emrosi (Minocycline Hydrochloride Extended Release Capsules, 40 mg, previously known as DFD-29, for the treatment of inflammatory lesions (papules and pustules) of rosacea in adults. The approval marks the first oral formulation of minocycline for the treatment of rosacea. 

Clinical trial insights 

The approval follows positive results from two pivotal Phase 3 clinical trials, MVOR-1 (NCT05296629) and MVOR-2 (NCT05343455). Both trials were designed as double-blind, placebo-controlled studies evaluating low-dose minocycline in comparison to low-dose modified-release doxycycline and placebo over a 16-week period. Participants presented with 15 to 60 inflammatory lesions at baseline. 

The trials assessed the following coprimary endpoints: 

• Investigator’s Global Assessment (IGA) success, with patients achieving a clear or almost clear status with at least a 2-grade improvement over placebo 
• Total inflammatory lesion count reduction compared to placebo 

Secondary endpoints encompassed: 

• Percentage change in total inflammatory lesion count compared to placebo 
• IGA treatment success in comparison to modified-release doxycycline 
• Reduction in total inflammatory lesion count relative to doxycycline 
• Clinician’s Erythema Assessment compared to placebo 
• Dermatology Quality of Life Index score changes from baseline versus placebo 

Both trials met all coprimary and secondary endpoints, with patients in the Emrosi group demonstrating statistically significant superiority over both modified-release doxycycline and placebo with no significant safety issues. 

Safety profile 

The most common adverse reaction reported by ≥1% of patients treated with Emrosi, at a greater frequency than those receiving placebo, was dyspepsia. Emrosi is contraindicated for patients who have a history of hypersensitivity to any of the tetracyclines. 

Future outlook 

Journey Medical is finalizing the manufacturing process for Emrosi in the US, with an anticipated product launch and initial supply availability projected for late in the first quarter or early in the second quarter of 2025.