Auris Medical Receives FDA and EMA Guidance for Keyzilen® Late-Stage Clinical Development Program
Auris Medical Holding AG (EARS)
Last auris medical holding ag earnings: 8/10 06:31 am
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ir.aurismedical.com
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Source: GlobeNewswire
Hamilton, Bermuda, Sept. 13, 2019 (GLOBE NEWSWIRE) -- Auris Medical Holding Ltd. (NASDAQ: EARS), a clinical-stage company dedicated to developing therapeutics that address important unmet medical needs in neurotology and central nervous system disorders, today announced that it has obtained advice on the development plan and regulatory pathway for its investigational tinnitus treatment Keyzilen® (AM-101) from the U.S. Food and Drug Administration (“FDA”) and from the European Medicines Agency (“EMA”). The Company had reached out to the two agencies in order to discuss and validate the design of a new Phase 2/3 trial for the Keyzilen® program. The advice was provided in the context of a Type C meeting and a Scientific Advice procedure, respectively. In their feedback, both the FDA and EMA supported the use of the Tinnitus Functional Index (TFI) questionnaire as the primary efficacy outcome measure. The TFI captures the impact of tinnitus on the patient’s day-to-day functioning
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