MedicalResearch.com Interview with:
CEO of Foamix
FightAcne.com: What is the background for this study? How does FMX101 differ from other antibiotics for acne, ie tetracycline, topical clindamycin etc?
Response: This study measures the safety and efficacy of a topical foam formulation of the antibiotic minocycline, for the treatment of moderate-to-severe acne.
Minocycline is one of the most commonly used products for the treatment of acne, but is currently only available in an oral dosage form.
Significant side effects are associated with oral minocycline, including GI upset, photosensitivity, headaches, dizziness, and other potential effects on the CNS. In addition to the side effects associated with oral minocycline, many currently available topical acne medications contain ingredients which can be drying and irritating to the skin. These side effects can be frustrating to patients and potentially impact overall compliance to their treatment regimen. The study addresses important unmet needs in dermatology to determine whether a topical dosage form of minocycline may also be effective in treating acne without these side effects.
In all three of our Phase 3 clinical studies, >95% of facial local tolerability signs and symptoms were classified as “none” or “mild,” including dryness, erythema and itching. Also, our topical 4% minocycline foam, FMX101, is a natural triglyceride-based vehicle that does not contain surfactants or other ingredients that commonly serve as primary irritants. We believe that FMX101, if approved, would be the first topical minocycline available for the treatment of acne and provide a novel and much needed treatment option for patients who suffer from the physical and psycho-social effects of acne.