Otonomy Initiates Phase 1/2 Clinical Trial of OTO-313 for Tinnitus
SAN DIEGO, CALIFORNIA — Otonomy has announced the initiation of a Phase 1/2 clinical trial of OTO-313 in patients with tinnitus. The randomized, double-blind, placebo-controlled Phase 1/2 study will include an initial safety cohort followed by an exploratory efficacy study that will enroll approximately 50 patients with subjective tinnitus. OTO-313 is said to be a…
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After Disappointing Results on Phase 3 Trial of Meniere’s Drug, Otonomy Lays off Staff, Suspends Further Trials in 2017
SAN DIEGO, CALIFORNIA — Following disappointing AVERTS-1 Phase 3 trial results of OTIVIDEX in Ménière’s disease patients, Otonomy, Inc., a US-based biopharmaceutical firm, announced that the company is laying off one-third of its noncommercial staff and will not initiate any further clinical trials through the end of 2017. With the announcement, the timing for initiation…
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Otonomy Enrolling Patients in Phase 2 Clinical Trial of OTO-104, to Prevent Cisplatin-Induced Hearing Loss
SAN DIEGO, CALIFORNIA — Otonomy, Inc., a US-based biopharmaceutical firm, announced the enrollment of its first patients in a Phase 2 clinical trial evaluating OTO-104 for prevention of hearing loss in cancer patients undergoing chemotherapy with platinum-based agents, such as cisplatin. This multicenter trial is designed to evaluate the feasibility, safety and efficacy of OTO-104,…
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FDA Fast Tracks Tinnitus Drug; Meniere’s Drug Completes Year-Long Safety Trial
ZUG, SWITZERLAND — Biopharmaceutical company Auris Medical Holdings announced late last month that the US Food and Drug Administration (FDA) granted Fast Track designation to its investigational drug, KeyzilenTM (AM-101). Keyzilen is esketamine gel for intratympanic injection, intended for acute peripheral tinnitus following cochlear injury or otitis media in adults. The Fast Track designation by the FDA of an…
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