Adamis announced that the Food and Drug Administration (FDA) has accepted for review the New Drug Application (NDA) for a higher dose naloxone injection product to treat opioid overdose. The Company submitted the NDA in January 2019.
Naloxone, an opioid antagonist, is used for the emergency treatment of known or suspected opioid overdose. It antagonizes opioid effects by competing for the same receptor sites. Naloxone reverses the effects of opioids, including respiratory depression, sedation, and hypotension.
Currently, naloxone is supplied in ampules and vials for IV, IM or SC administration, in a prefilled auto-injector, and as a nasal spray. The FDA has set a Prescription Drug User Fee Act (PDUFA) date of October 31, 2019 for the NDA.
In December 2018, a joint meeting of the Anesthetic and Analgesic Products Advisory Committee and the Drug Safety and Risk Management Advisory Committee voted in favor of adding language to opioid analgesic labeling to recommend co-prescription of naloxone for all or some patients prescribed opioids.
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