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# Auris Medical Get FDA Buy-in for Pivotal Trial
- URL: https://www.fdaweb.com/auris-medical-get-fda-buy-in-for-pivotal-trial/
- Published: 2018-08-30T12:00:00.000Z
- Updated: 2026-09-15T00:29:00.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5142240

FDA has approved Auris Medical’s proposed choice of primary and secondary efficacy endpoints, the safety endpoints, as well as the planned sample size and statistical methodology for a pivotal Phase 3 trial of AM-111 (brimapitide), an investigational treatment for sudden sensorineural hearing loss. In a recent meeting with the agency, the company discussed the results of the HEALOS Phase 3 trial, which showed a clinically meaningful and nominally significant improvement in hearing for the AM-111 0 group compared to placebo in the subpopulation of patients with acute profound hearing loss, the company says.

  
Auris says AM-111 is being developed in a biocompatible gel formulation for treating sudden sensorineural hearing loss with a single-dose administration into the middle ear. The cell-penetrating peptide is designed to inhibit the JNK stress kinase, which is activated following various types of cochlear stress that cause acute inner ear hearing loss and plays a key role in apoptosis of sensory cells as well as in inflammatory responses, the company says.