Foamix announces publication of AMZEEQ topical foam long-term safety data
Foamix Pharmaceuticals announced the peer review publication of the long term open label safety portions of studies FX2014-04 and FX2014-05 in the Journal of Clinical and Aesthetic Dermatology. Studies 04 and 05 were conducted by Foamix to support the New Drug Application submission of AMZEEQ topical foam, which was approved by the U.S. Food and Drug Administration for the treatment of inflammatory lesions of non-nodular moderate to severe acne vulgaris in patients 9 years of age and older. Highlights from the Long-Term Safety Program: The open-label safety portions of Studies 04 and 05 enrolled a total of 657 patients, all of whom had completed 12 weeks of AMZEEQ topical foam, 4% or vehicle treatment in the preceding double-blind phases of these studies. Patients continued for up to an additional 40 weeks of open-label treatment with AMZEEQ. Of those enrolled in this safety study, 291 completed a total of 52 weeks of therapy. The key findings from the study are as follows: 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, 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. No serious drug-related adverse events were reported.