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.
FightAcne.com: What are the main findings?
Response: The results from our third confirmatory Phase 3 study show that both co-primary endpoints were met, 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 reflect highly statistically significant results to support a finding that FMX101, if approved, would be a safe and effective treatment for moderate-to-severe acne.
FightAcne.com: Does topical minocycline have the side effects of oral minocycline, ie pigmentation? Is it photosensitizing? Do non-inflammatory lesions also improve?
Response: Oral minocycline has been around for decades and is effective in treating acne. However, oral antibiotics like minocycline have a number of systemic side effects that limit its use by patients who could potentially see meaningful improvement in their acne with them. Foamix is trying to address this issue by developing a topical foam that has the potential to safely and effectively deliver minocycline directly to the acne-affected area without the systemic side effects associated with oral antibiotics.
The classical blue or grey change in skin tone that has occurred from prolonged use of systemic minocycline (minocycline-induced hyperpigmentation) was closely monitored in our clinical studies. Investigators were trained to classify this pigment change as an adverse event. In the three 12 week phase 3 studies, as well as the 52 week long-term study, no adverse events due to changes in pigment were recorded. The same can be said for photosensitivity, as FMX101 did not induce phototoxicity or photoallergic responses in dermal safety studies.
FightAcne.com: Do non-inflammatory lesions also improve?
Response: FMX101 was also shown to be effective in treating non-inflammatory lesions (open and closed comedones). Results from our study showed statistically significant improvement in reduction of non-inflammatory lesions between treatment groups.
FightAcne.com: What should readers take away from your report?
Response: The data from our recent study are impressive and suggest that it may offer patients with acne an effective treatment that is easy to use, gentle on the skin, and [generally] free from the systemic side effects typically associated with oral antibiotics.
FightAcne.com: Is there anything else you would like to add?
Response: We are thrilled with the results of our latest study with FMX101 and we now stand poised to submit our first New Drug Application with the FDA, bringing us one step closer to providing a novel treatment option to the millions of people suffering from acne.
We are also nearing the end of our Phase 3 trial with FMX103, 1.5% minocycline foam, for the treatment of moderate-to-severe papulopustular rosacea. If approved, this would be the first topical minocycline available for patients with moderate-to-severe papulopustular rosacea. Results from our Phase 2 trial with FMX103 demonstrated statistically significant efficacy in reduction of inflammatory lesions in patients. We look forward to reviewing the results of our Phase 3 trial in rosacea this year.
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