Otoprotectants: From Research to Clinical Application

Abstract

There is an urgent need for otoprotective drug agents. Prevention of noise-induced hearing loss continues to be a major challenge for military personnel and workers in a variety of industries despite the requirements that at-risk individuals use hearing protection devices such as ear plugs or ear muffs. Drug-induced hearing loss is also a major quality-of-life issue with many patients experiencing clinically significant hearing loss as a side effect of treatment with life-saving drug agents such as cisplatin and aminoglycoside antibiotics. There are no pharmaceutical agents approved by the United States Food and Drug Administration for the purpose of protecting the inner ear against damage, and preventing associated hearing loss (otoprotection). However, a variety of preclinical studies have suggested promise, with some supporting data from clinical trials now being available as well. Additional research within this promising area is urgently needed.

Keywords

otoprotection - ototoxicity - noise-induced hearing loss - drug-induced hearing loss

Disclosure

Funding for previously completed clinical trials evaluating prevention of temporary threshold shift in humans was provided by U01 DC 008423 from the National Institutes of Health – National Institute on Deafness and other Communication Disorders (NIH-NIDCD). Clinical trial material used in that study included a tablet formulation of ACEMg developed by OtoMedicine, Inc. and a capsule formulation of ACEMg developed by Hearing Health Sciences, Inc. Specifically, NCT00808470 was a clinical trial completed at the University of Florida under the oversight of C. Le Prell with funding from the National Institutes of Health using clinical trial material provided by Hearing Health Science, Inc., and the study completed by the Karolinska Institute team was coordinated out of the University of Florida by C. Le Prell with funding from the National Institutes of Health and using clinical trial material provided by OtoMedicine, Inc. Additional funding and clinical trial material were provided via contracts to the University of Florida by Sound Pharmaceuticals, Inc. (Ebselen, SPI-105) and Edison Pharmaceuticals, Inc. (Vincerinone, EPI-743). Specifically, NCT01444846 was a clinical trial completed at the University of Florida under the oversight of C. Le Prell with funding and clinical trial material provided by Sound Pharmaceuticals Inc. and NCT02257983 was a clinical trial completed at the University of Florida under the oversight of C. Le Prell with funding and clinical trial material provided by Edison Pharmaceuticals, Inc. Colleen Le Prell consults with various pharmaceutical companies engaged in the development of novel agents with potential auditory applications on an ongoing basis.

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