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Fitzgerald Health Education Associates, Inc., January 2015 fhea.com
New Drug Approved for Swimmer's Ear
The FDA approved finafloxacin otic suspension (Xtoro)
for the treatment of acute otitis externa caused by Pseu -
domonas aeruginosa and Staphylococcus aureus. Xtoro is
the newest fluoroquinolone antimicrobial to be ap-
proved by the FDA. It is a product of Alcon Laboratories.
The safety and efficacy of Xtoro were tested in two
clinical trials involving 1234 participants between 6
months and 85 years of age. The participants were
randomly assigned to receive Xtoro or its vehicle. Clin-
ical cure was considered to be achieved if ear tender-
ness, redness, and swelling were completely resolved.
Among 560 participants whose acute otitis externa
was confirmed to be caused by P. aeruginosa or S. au-
reus, 70% who received Xtoro achieved clinical cure
versus 37% who received vehicle. Based on ear cul-
ture, Xtoro was also shown to be superior to vehicle
for clearing the bacteria, and Xtoro eased ear pain
sooner than vehicle.
The most common adverse events reported in the
clinical trials of Xtoro among patients who were given
Xtoro were pruritus of the ear and nausea.
New Insomnia Medication Approved
Suvorexant (Belsomra) tablets were approved by the
FDA for use as needed to treat insomnia. The medica-
tion is the first orexin receptor antagonist to be ap-
proved in the United States. Orexins are involved in
regulating the sleep-wake cycle and play a role in
keeping people awake. Suvorexant works by altering
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