OTO-201 for the Treatment of Acute Otitis Externa: Results from a Phase 3 Randomized Clinical Study.
CONCLUSIONS:: In this study in subjects with acute otitis externa, a single administration of 12 mg OTO-201 to the external auditory canal demonstrated a significantly higher proportion of subjects with CC and bacterial eradication compared with sham starting on day 4 and on all other observation days through day 29, with no safety or tolerability concerns identified. OTO-201 is the first agent in a randomized phase 3 study to demonstrate the efficacy and safety of a single-dose, health care professional-administered topical antibiotic for the treatment of acute otitis externa.
PMID: 30829050 [PubMed - as supplied by publisher]
Source: The Annals of Otology, Rhinology, and Laryngology - Category: ENT & OMF Authors: Ansley J, Mair EA, Namini H, Lu CH, LeBel C Tags: Ann Otol Rhinol Laryngol Source Type: research
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