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Otonomy Announces Positive Results from Two Phase 3 Trials of AuriPro™ in Pediatric Patients Undergoing Ear Tube Placement Surgery

July 23, 2014



By a News Reporter-Staff News Editor at Biotech Week -- Otonomy, Inc., a clinical-stage biopharmaceutical company focused on the development and commercialization of innovative therapeutics for diseases and disorders of the inner and middle ear, announced positive results from two identical Phase 3 trials of AuriPro™ in a combined total of 532 pediatric patients with bilateral middle ear effusion requiring tympanostomy tube placement. In both trials, AuriPro achieved the primary efficacy endpoint with statistical significance (pOtonomy, Inc.).

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"We are pleased with these results and plan to continue to progress forward to filing for regulatory approval of AuriPro in the United States," said David A. Weber, Ph.D., president and chief executive officer of Otonomy.

The prospective, randomized, double-blind, sham-controlled Phase 3 studies enrolled subjects, ages six months to 17 years old, across approximately 60 trial sites in the United States and Canada. The primary endpoint of the studies was the effectiveness of AuriPro as measured by the cumulative proportion of study treatment failures through day 15, which is defined as the presence of otorrhea (drainage) or use of antibiotic rescue medication. Otonomy plans to present the full results at an appropriate medical meeting in the future.

Keywords for this news article include: Surgery, Pediatrics, Otonomy Inc..

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Source: Biotech Week


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