FDA accepts NDA for higher naloxone injection for the treatment of opioid overdose
Adamis Pharmaceuticals Corporation announced that the FDA has accepted for review the company’s New Drug Application (“NDA”) for its higher naloxone injection product candidate for the treatment of opioid overdose.
On March 14, 2019, Adamis received FDA correspondence relating to the company’s NDA stating that the Agency had completed its filing review and had determined that the NDA was sufficiently complete to permit a substantive review. The FDA further provided a target agency action date of 31 October 2019.
Comment: Adamis’ naloxone product candidate uses a similar pre-filled syringe injection platform as is used in its FDA-approved Symjepi product for treatment of allergic reactions (Type I) including anaphylaxis.
Comment: An article entitled “Higher doses of naloxone are needed in the synthetic opioid era” has been published in the peer reviewed journal Substance Abuse Treatment, Prevention, and Policy. (https://substanceabusepolicy.biomedcentral.com/articles/10.1186/s13011-019-0195-4) .The article notes the dramatic increase in deaths due to illicit use of the opioid fentanyl, reviews the literature on the number of repeat doses of naloxone to treat fentanyl overdoses, reviews the pharmacology of naloxone and fentanyl, and provides a rationale for using higher doses of naloxone as an effective countermeasure.
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