NAPSR News: FDA approves new swimmer’s ear treatment

WASHINGTON - Dec. 18, 2014 - PRLog -- The U.S. Food and Drug Administration has approved Xtoro (finafloxacin otic suspension) to treat acute otitis externa commonly referred to as swimmer's ear. Xtoro belongs to the fluoroquinolone antimicrobial drug class and joins other antibacterial drug products previously approved to treat ear infections.

Swimmer’s ear (Acute otitis) is caused by Pseudomonas aeruginosa and Staphylococcus aureus which infects the outer ear and ear canal.  The infection usually develops when water remains in the ear after swimming or from other underwater activities; the moist environment leads to bacterial growth. The ear then becomes enflamed resulting in pain, swelling, redness and discharge.

“The availability of multiple treatment options allows physicians and patients to find the treatment to meet their needs,” said Edward Cox, M.D., M.P.H., director of the Office of Antimicrobial Products in the FDA’s Center for Drug Evaluation and Research.

FDA Approval was based on the results of two clinical trials involving 1,234 individuals between the ages of 6 months and 85 years who were randomly assigned Xtoro or given its vehicle (a solution without a fluoroquinolone). 70 percent of the 560 participants whose acute otitis externa was confirmed to be caused by Pseudomonas aeruginosa or Staphylococcus aureus achieved the clinical cure of ear ternderness, redness and swelling being completely resolved after receiving Xtoro. Clinical data also revealed Xtoro’s superiority to the vehicle for bacterial clearance based on ear culture and the alleviation of ear pain.

Xtoro is manufactured by Alcon Laboratories.

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