XTORO (finafloxacin)

Finafloxacin plasma concentrations were evaluated following single or repeated ototopical doses of XTORO (finafloxacin otic suspension) 0.3%. In healthy subjects administered 4 drops in each ear twice daily for seven days, quantifiable finafloxacin concentrations were observed in 2 of 14 subjects; and these concentrations were just above the quantitation limit (0.05 ng/mL). Similarly, in AOE patients administered a single dose of 4 or 8 drops in each ear, quantifiable finafloxacin concentrations...

In two randomized multicenter, vehicle controlled clinical trials, XTORO dosed four drops twice daily for 7 days was superior to its vehicle for both clinical and microbiological outcomes as well as in time to cessation of ear pain in patients with acute otitis externa (AOE). Among 560 patients (161 with an otowick) that were pathogen positive (baseline microbiological specimen that contained Staphylococcus aureus and/or Pseudomonas aeruginosa ), clinical cure on Day 11 was 71% in XTORO versus 37% in Vehicle. Among 1234 patients who received study treatment (Intent to Treat population (ITT)), ...

The most common adverse reactions occurring in 1% of patients with XTORO were ear pruritus and nausea. ( 6 ) To report SUSPECTED ADVERSE REACTIONS, contact Fonseca Biosciences, LLC at 1-877-436-6732 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch. 6.1 Clinical Trials Experience Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may ...

None. None. ( 4 )

Prolonged use of this product may lead to overgrowth of nonsusceptible organisms. Discontinue use if this occurs. ( 5.1 ) Allergic reactions may occur in patients with a history of hypersensitivity to finafloxacin, to other quinolones, or to any of the components in this medication. Discontinue use if this occurs. ( 5.2 ) 5.1 Growth of Resistant Organisms with Prolonged Use As with other antibacterial preparations, prolonged use of XTORO may lead to overgrowth of nonsusceptible organisms, includ...