Clinical Data
This Phase 1 study was intended to characterize the systemic absorption of minocycline after repeated maximum dose applications of FMX-101 in subjects with moderate-to-severe acne and, by so doing, to provide a clinical bridge to minocycline systemic safety data known to the FDA.The objectives of the study were:

• To characterize minocycline pharmacokinetics following multiple-dose administration of FMX-101 minocycline foam, 4% in subjects with acne vulgaris.
• To assess the relative bioavailability of FMX-101 minocycline foam, 4%, compared to Solodyn® (minocycline HCl) extended release tablets.

This Phase 1 study was a single-center, nonrandomized, open-label, active-controlled, 2-period, 2-treatment evaluation of multiple-dose topical administration of FMX-101 minocycline foam, 4%, compared to oral administration of Solodyn (minocycline HCl) extended-release tablets in subjects with moderate-to-severe facial acne vulgaris and acne additionally affecting at least 2 of the following regions: neck, upper chest, upper back, arms. 30 subjects were enrolled in 3 cohorts, and 30 subjects completed the study. 30 subjects received a single dose of Solodyn tablets, and 1 week later they received FMX-101, 4% minocycline foam, for 21 days. Solodyn was orally administered as a single dose of 1 mg/kg in accordance to its approved instructions for use. 4 grams of FMX-101, 4% was applied topically once daily for 21 days.Top line results indicate that the relative bioavailability (systemic exposure) of FMX-101 was more than 100 times lower than that for Solodyn. FMX-101 was well tolerated, and no serious adverse events were reported in the study.