Studies FX2014-04 and FX2014-05 of Amzeeq for acne published in Journal of Clinical and Aesthetic Dermatology.- Foamix Pharma

Foamix Pharmaceuticals announced the peer review publication of the long term open label safety portions of studies FX2014-04 and FX2014-05 (Studies 04 & 05) of Amzeeq (minocycline) topical foam for Acne, in the Journal of Clinical and Aesthetic Dermatology. Studies 04 and 05 were conducted by Foamix to support the New Drug Application submission of minocycline topical foam, which was approved by the FDA for the treatment of inflammatory lesions of non-nodular moderate to severe acne vulgaris in patients 9 years of age and older.

The key findings from the study showed that subject satisfaction with Amzeeq treatment remained high when re-assessed at Week 52 which was consistent with scores obtained at Week 12. Application site adverse events occurred in less than 2% of patients during the additional 40 weeks of open-label treatment with Amzeeq.

In the assessment of facial dermal tolerability at Week 52, more than 95% of patients had "none" or "mild" signs and symptoms (erythema, dryness, hyperpigmentation, peeling, and itching), and no severe local tolerability scores were recorded. Non-dermal adverse events were comparable in type and frequency with those reported during the double-blinded portions of each study. The most frequently reported treatment-emergent adverse event was nasopharyngitis (common cold). No serious drug-related adverse events were reported.