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FDA Approves Finafloxacin Otic Suspension
An otic suspension of finafloxacin has been approved by the FDA to treat acute otitis externa, commonly known as “swimmer’s ear,” caused by Pseudomonas aeruginosa and Staphylococcus aureus.
Positive results were recently reported from a phase II trial in which approximately 200 patients hospitalized with complicated urinary-tract infections were treated with finafloxacin. The results from this study demonstrated positive outcomes at all primary and secondary endpoints. Patients treated once daily for 5 days with finafloxacin demonstrated higher levels of microbiologic eradication and improved clinical outcomes compared with those treated with the current standard of care (ciprofloxacin taken twice daily for 10 days).
According to the product’s developer (MerLion Pharmaceuticals), finafloxacin is a fluoroquinolone antibiotic used in the treatment of severe infections, including those caused by resistant Gram-negative pathogens. In the hostile acidic conditions existing at the sites of nearly all infections, finafloxacin has demonstrated substantially higher uptake and accumulation in bacterial cells compared with that of the current “gold standard,” as well as superior binding of the molecule to its two fluoroquinolone targets. Most other antibiotics, including other fluoroquinolones, have decreased activity in these acidic conditions, MerLion says.
Both intravenous (IV) and oral formulations of finafloxacin, with equivalent bioavailability, have been developed, offering physicians the choice of initially treating infections in the hospital or at out-patient infusion centers for 1 to 3 days with the IV regimen, and then allowing patients to complete their treatment at home, thereby reducing the risk of complications and/or secondary infections.
Acute otitis externa is an infection in the outer ear and ear canal, usually caused by bacteria in the ear canal. Activities in which the ear is underwater can create a moist environment in which bacteria may grow. The infection causes inflammation of the ear canal leading to pain, swelling, redness of the ear, and discharge from the ear.
Source: MerLion Pharmaceuticals; February 11, 2015.