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A Phase III, placebo-controlled, pivotal trial of AM-111 (0.4 mg/mL) in patients suffering from acute profound hearing loss

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Trial Profile

A Phase III, placebo-controlled, pivotal trial of AM-111 (0.4 mg/mL) in patients suffering from acute profound hearing loss

Status: Planning
Phase of Trial: Phase III

Latest Information Update: 25 Aug 2022

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At a glance

  • Drugs Brimapitide (Primary)
  • Indications Sensorineural hearing loss
  • Focus Therapeutic Use

Most Recent Events

  • 12 Sep 2018 New trial record
  • 30 Aug 2018 According to an Auris Medical media release, the company had a Type C meeting with the U.S. Food and Drug Administration (FDA). The FDA has provided guidance regarding the endpoints, design of the trial, the planned sample size, statistical methodology and the regulatory path forward. This trial design also incorporates specific feedback provided by the European Medicines Agency (EMA) earlier this year.

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