29Nov 2023
FDA Accepts Orexo's New Drug Application for OX124, a high-dose rescue medication for opioid overdose

FDA Accepts Orexo's New Drug Application for OX124, a high-dose rescue medication for opioid overdose

Orexo AB (publ.) announces that the US Food and Drug Administration (FDA) has accepted the New Drug Application (NDA) for OX124. OX124, a nasal rescue medication for opioid overdose, contains a high dose of naloxone and utilizes Orexo's drug delivery platform, amorphOX®. OX124 addresses the rising demand for potent medications to counter synthetic opioid overdoses, especially those caused by fentanyl. The innovative amorphOX technology enhances stability and temperature resistance. OX124, aims to be a reliable rescue medication, potentially benefitting from recent FDA approvals of non-prescription overdose products.

  • #general medicine

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