San Diego-based Otonomy Inc., a company that makes treatments for the middle and inner ear, is enrolling the first patients in a Phase 3 clinical trial of OTO-104 for Ménière’s disease, an inner ear disorder characterized by severe dizziness, vertigo, and gradual hearing loss.
The company expects to enroll roughly 160 patients in the trial at clinical sites throughout the U.S.
Otonomy intends to conduct two parallel Phase 3 trials in Ménière's disease. The first Phase 3 trial is already underway, and a second trial is expected to begin in the European Union during the first quarter of 2016, according to a news release. Results of both Phase 3 trials are expected in the second half of 2017.
OTO-104 has been granted fast-track designation from the U.S. Food and Drug Administration, which could speed the development and review of the drug. The designation emphasizes frequent communication between the FDA and the drug developers to improve the efficiency of product development.