Minocycline foam 4% (Amzeeq; Foamix) appears to be safe and effective for moderate-to- severe acne, according to findings from a long-term, open-label safety study.
The 52-week study included patients from 2 double-blind studies (FX2014-04 and FX2014-05) who completed 12 weeks of treatment with minocycline foam 4% (n=657). These patients continued treatment with the topical therapy for an additional 9 months.
At Week 52, study findings showed that treatment with minocycline foam continued to reduce inflammatory lesions and was associated with Investigator’s Global Assessment treatment success. Moreover, patient satisfaction remained high with minocycline foam which was consistent with scores obtained at Week 12.
Application site reactions occurred in <2% of patients during the open-label study. Additionally, the assessment of facial dermal tolerability at Week 52 showed >95% of patients had “none” or “mild” signs and symptoms; no severe local tolerability scores were recorded. The most common treatment-emergent non-dermal adverse event was nasopharyngitis.
The Food and Drug Administration (FDA) recently approved Amzeeq as the first topical minocycline treatment for inflammatory lesions of non-nodular moderate to severe acne vulgaris in patients aged ≥9 years. Amzeeq uses Foamix’s proprietary Molecule Stabilizing Technology (MST) platform to deliver minocycline, a tetracycline-class drug, in a foam formulation
The Company expects Amzeeq to be available in January 2020. The product will be supplied in a 30-gram aerosol container.
For more information visit foamix.com.