“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.
Xtoro’s safety and efficacy were primarily established in two clinical trials where 1,234 participants between the ages of 6 months and 85 years were randomly assigned to receive Xtoro or its vehicle (a solution without a fluoroquinolone). Clinical cure was achieved if the ear tenderness, redness and swelling were completely resolved.
Among 560 participants whose acute otitis externa was confirmed to be caused by Pseudomonas aeruginosa or Staphylococcus aureus, 70 percent who received Xtoro achieved clinical cure versus 37 percent who received the vehicle. In addition, Xtoro was superior to the vehicle for clearing the bacteria based on ear culture, and eased ear pain sooner than the vehicle.
The most common side effects reported in Xtoro-treated participants were itching of the ear (pruritis) and nausea.
Xtoro is manufactured Alcon Laboratories, Inc., based in Fort Worth, Texas.
Source: FDA
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ARYAN'S BLOG 