- Non-dermal adverse events were comparable in type and frequency with those reported during the double-blinded portion of FX2014-04 and FX2014-05. The most frequently reported treatment-emergent adverse event was nasopharyngitis (common cold). In the open-label extension, 3 patients discontinued the study for non-dermal adverse events - abdominal pain (2 patients), back pain (1 subject). No serious drug-related adverse events were reported.
- Application site adverse events occurred in less than 2% of patients during the additional 40 weeks of open-label treatment with FMX-101. Four patients discontinued in the study for an application site adverse event - worsening of acne (2 patients), contact dermatitis (one subject), and localized facial edema (1 subject). 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.
- Subject satisfaction with FMX-101 treatment remained high when re-assessed at Week 52 which was consistent with scores obtained at Week 12 (end of double-blind phase).
Data from this study will be presented in a poster forum at the Winter Clinical Dermatology Conference to be held January 12 th - 17 th at the Hyatt Regency in Maui, Hawaii. In addition, Foamix will also present the following posters from the FMX-101 development program at the conference:
- Pharmacokinetic Evaluation of Once-Daily Topical 4% Minocycline Foam in Adult and Pediatric Patients with Moderate-to-Severe Acne in Two Phase 1 Studies
- The Efficacy and Safety of FMX101, Minocycline Foam 4%, for the Treatment of Acne Vulgaris: A Pooled Analysis of Two Phase 3 Studies
Contact: Ilan HadarFoamix Pharmaceuticals Ltd.+972-8-9316233 IR@foamixpharma.comU.S. Investor Relations Michael RiceLifeSci Advisors, LLC646-597-6979 email@example.com