Intratympanic Administration of OTO-313 Reduces Tinnitus in Patients With Moderate to Severe, Persistent Tinnitus: A Phase 1/2 Study.

Autor:	Maxwell KS; Piedmont ENT, Winston-Salem, North Carolina., Robinson JM; Otonomy Inc., San Diego, California., Hoffmann I; Otonomy Inc., San Diego, California., Hou HJ; Otonomy Inc., San Diego, California., Searchfield G; University of Auckland, Auckland, New Zealand., Baguley DM; Mental Health and Clinical Neurosciences, School of Medicine.; National Institute for Health Research Biomedical Research Centre, University of Nottingham.; Nottingham Audiology Services, Nottingham University Hospitals, Nottingham, UK., McMurry G; ENT & Allergy Associates, Louisville, Kentucky., Piu F; Otonomy Inc., San Diego, California., Anderson JJ; Otonomy Inc., San Diego, California.
Jazyk:	angličtina
Zdroj:	Otology & neurotology : official publication of the American Otological Society, American Neurotology Society [and] European Academy of Otology and Neurotology [Otol Neurotol] 2021 Dec 01; Vol. 42 (10), pp. e1625-e1633.
DOI:	10.1097/MAO.0000000000003369
Abstrakt:	Objective: To evaluate the safety and exploratory efficacy of intratympanic administration of OTO-313 in patients with tinnitus. Study Design: Single intratympanic injection of OTO-313 evaluated in a randomized, double-blind, placebo-controlled Phase 1/2 clinical study. Setting: Tertiary referral centers. Patients: Patients with unilateral tinnitus (moderate-severe) with tinnitus duration 1 to 6 months. Interventions: Intratympanic OTO-313. Main Outcome Measures: Safety and change from baseline in tinnitus functional index (TFI), daily ratings of tinnitus loudness and annoyance, and patient global impression of change (PGIC). Results: OTO-313 was well-tolerated with lower incidence of adverse events than placebo. Mean TFI reduction from baseline favored OTO-313 at Week 2, 4, and 8. A clinically meaningful, 13-point improvement on the TFI was observed in 43% (6/14) of OTO-313 patients at both Weeks 4 and 8 versus 13% (2/16) of placebo patients (ad hoc responder analysis, p-value < 0.05). Reductions in daily ratings of tinnitus loudness and annoyance favored OTO-313 compared with placebo. In OTO-313 responders, a strong correlation existed between change from baseline in TFI score and changes in tinnitus loudness, tinnitus annoyance, and PGIC. Conclusions: OTO-313 was well-tolerated and demonstrated a higher proportion of responders than placebo across consecutive visits (Weeks 4 and 8) supporting further clinical development of OTO-313 for the treatment of tinnitus. Competing Interests: Disclosure Summary: K.S.M.: Employee of Piedmont ENT. No conflicts of interest to declare. (Copyright © 2021 The Author(s). Published by Wolters Kluwer Health, Inc. on behalf of Otology & Neurotology, Inc.)
Databáze:	MEDLINE
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