Development of Drugs for Noise-Induced Hearing Loss

Abstract

Current efforts to translate laboratory findings into clinical drugs for preventing or treating sensorineural hearing loss (SNHL) are reviewed in this chapter. Since no drugs have been approved for any inner ear indication involving SNHL, including tinnitus, this is a novel area of both clinical development and regulatory oversight. An overview of FDA guidance, and sponsor interactions or meetings with the FDA, involving preclinical data to clinical trial design and regulatory approval are reviewed. Specific steps on how to evaluate the safety and efficacy of an investigational new drug through a series of well-controlled preclinical (nonhuman) and clinical (human) studies are provided. The information presented is designed to assist researchers and clinicians in mapping out and executing an effective drug development program. In this chapter, regulatory considerations for the development of a new or existing drug that reduces, mitigates, prevents, or treats noise-induced hearing loss (NIHL) are reviewed, including both preclinical and clinical FDA interactions, followed by a detailed discussion of the investigational drugs that are furthest along in clinical testing.