New data announced in moderate-to-severe papulopustular rosacea trials

Foamix Pharmaceuticals announced positive safety and efficacy data for its Phase III open-label safety study (FX2016-13), evaluating FMX 103 (minocycline foam 1.5%) in moderate-to-severe papulopustular rosacea for a treatment period of up to 1 year. The open-label safety study enrolled a total of 505 patients, all of whom had completed 12 weeks of FMX 103 or vehicle treatment in the preceding double-blind studies (FX2016-11 or FX2016-12). Patients continued on open-label treatment with FMX 103 for up to an additional 40 weeks. Four hundred and sixty-five (465) patients received FMX 103 therapy for at least 26 weeks and 272 patients received FMX 103 therapy for a total of 52 weeks, which is in excess of the subject sample size requirements specified in the regulatory guidance for this type of safety evaluation (ICH E1A, 1995). A total of 410 patients completed participation in the study.

The key safety findings from the study are as follows: Non-cutaneous adverse events were comparable in type and frequency with those reported during the double-blinded portion of studies FX2016-11 and FX2016-12. The most frequently reported treatment-emergent adverse event was upper respiratory tract infection i.e. common cold (3.8%). Four (4) patients discontinued the study due to a non-application site adverse event – mydriasis, anemia/leukocytosis, appendicitis and enchondromatosis. No serious drug-related adverse events were reported. Cutaneous adverse events occurred in 1% or less of patients during the additional 40 weeks of open-label treatment with FMX103 with the most frequently reported treatment emergent adverse event being contact dermatitis (1.0%). Two (2) patients discontinued in the study for an application site adverse event – worsening of rosacea and contact dermatitis.

In the assessment of facial dermal tolerability at Week 52, more than 95% of patients had either no signs or symptoms, or signs/symptoms that were classified “mild” (burning/stinging, flushing/blushing, dryness, itching, peeling and hyperpigmentation). The severity of key clinical manifestations of rosacea - erythema and telangiectasia - had both significantly improved when compared to Baseline of the preceding double-blind studies. Patient satisfaction with FMX103 treatment remained high when re-assessed at Week 52 which was consistent with scores obtained at Week 12 (end of double-blind studies).