MedicalResearch.com: What is the background for this study? How does FMX101 differ from other treatment for acne, ie benzoyl peroxide, 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 providing patients with a topical dosage form of minocycline may have potential advantages over existing products.
In our first two 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 minocycline foam, FMX101, is a natural triglyceride-based vehicle that does not contain ingredients that serve as primary irritants or surfactants. 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.
MedicalResearch.com: What are the main findings?
Response: The study met both co-primary endpoints, including absolute change from baseline in inflammatory lesion count at Week 12 and Investigator Global Assessment (“IGA”) treatment success at Week 12. This was defined as an IGA score of 0 or 1, meaning that patients’ skin was either “clear” or “almost clear” and at least a 2-grade improvement (decrease) from baseline. No treatment related serious adverse events were reported and the most commonly reported adverse event in the study was viral upper respiratory tract infection. Overall, the data reflects highly statistically significant efficacy results to support a finding that FMX101, if approved, would be a safe and effective treatment for moderate-to-severe acne.
MedicalResearch.com: What should readers take away from your report?
Response: The data from this confirmatory Phase 3 study are impressive, and brings Foamix closer to providing a new treatment option for patients with acne.
MedicalResearch.com: Are there restrictions on the use of topical minocycline, ie pregnancy, sun exposure, risk of skin pigmentation?
Response: As FMX101 has not been approved yet, we do not have the final label for use. As far as safety, our completed clinical study demonstrated that FMX101 is well tolerated with no treatment-related serious adverse events and very low dermal side effects.
MedicalResearch.com: Is there anything else you would like to add?
Response: We are incredibly excited about the results from this Phase 3 trial and believe that this represents a major milestone for the company. We are preparing to file the company’s first New Drug Application (NDA) with the U.S. FDA. We look forward to providing additional results from this latest Phase 3 study as they become available.
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