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.