Efficacy and safety of AM-111 in the Treatment of Acute Inner Ear Hearing Loss.

Trial Profile

Efficacy and safety of AM-111 in the Treatment of Acute Inner Ear Hearing Loss.

Completed
Phase of Trial: Phase III

Latest Information Update: 07 May 2018

At a glance

  • Drugs Brimapitide (Primary)
  • Indications Sensorineural hearing loss
  • Focus Registrational; Therapeutic Use
  • Acronyms HEALOS
  • Sponsors Auris Medical
  • Most Recent Events

    • 07 May 2018 According to an Auris Medical media release, based on the result from this study, the company has received positive Scientific Advice from the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA). The company is also planning for a Type C meeting with the US FDA.
    • 04 Jan 2018 Pooled results from this and a phase II trial, published in an Auris Medical media release.
    • 04 Jan 2018 Results of post hoc analysis published in an Auris Medical media release.
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