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Otiprio yields positive response in Phase 3
February 2017
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SAN DIEGO—Otonomy Inc. is starting the year with positive results from its pivotal Phase 3 clinical trial of Otiprio (ciprofloxacin otic suspension) in patients with acute otitis externa, or swimmer’s ear. The trial met its primary endpoint, with a statistically significant increase seen in clinical cure rate compared to no treatment at day 8, and also proved to be well tolerated. Given the promising response, Otonomy plans to submit a supplemental NDA with the FDA in the first half of this year.
 
Dr. David A. Weber, president and CEO of Otonomy, said “This trial reinforces Otiprio’s unique profile as a single-dose product administered by a physician thereby eliminating the risk of patient non-compliance with the use of multi-dose, multi-day ear drops. Furthermore, the fact that approximately 70 percent of patients in this trial were treated by non-ENT physicians supports the utility of Otiprio outside the ENT specialist audience.”

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