For Immediate Release
December 17, 2014
The U.S. Food and Drug Administration today approved Xtoro (finafloxacin otic suspension), a new drug used to treat acute otitis externa, commonly known as swimmer’s ear.
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 where bacteria may sometimes grow. The infection causes inflammation of the ear canal leading to pain, swelling, redness of the ear and discharge from the ear.
Xtoro is an eardrop approved to treat acute otitis externa caused by Pseudomonas aeruginosa and Staphylococcus aureus. Xtoro is the newest drug belonging to the fluoroquinolone antimicrobial drug class to be approved by the FDA. It joins several other antibacterial drug products previously approved to treat ear infections.
“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.
The FDA, an agency within the U.S. Department of Health and Human Services, protects the public health by assuring the safety, effectiveness, and security of human and veterinary drugs, vaccines and other biological products for human use, and medical devices. The agency also is responsible for the safety and security of our nation’s food supply, cosmetics, dietary supplements, products that give off electronic radiation, and for regulating tobacco products.