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US FDA grants investigational new drug approval for Sensorion to proceed with SENS-401.

M2 PHARMA-July 16, 2019-US FDA grants investigational new drug approval for Sensorion to proceed with SENS-401

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The US Food and Drug Administration (FDA) has granted investigational new drug approval (IND) to France-based Sensorion to proceed with SENS-401, based on preclinical data and clinical development plan, it was reported yesterday.

SENS-401 is under development for the treatment of Sudden Sensorineural Hearing Loss (or SSNHL). The product, arazasetron besylate, is a drug candidate that intends to protect and preserve inner ear tissue from damage that can cause progressive or sequelar hearing impairment.

The company started the Phase two clinical trial in this indication in 2019 in Europe, Canada, Israel and Turkey. The interim safety results are likely to be revealed at the end of 2019 and top line data will be announced mid-2020.

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Publication:M2 Pharma
Date:Jul 16, 2019
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