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: Tags: Ann Otol Rhinol Laryngol Source Type: research