The Food and Drug Administration (FDA) has issued a Complete Response Letter (CRL) to Adamis Pharmaceuticals regarding the New Drug Application (NDA) for Zimhi, an investigational high-dose naloxone injection product, for the treatment of opioid overdose. 

According to Adamis, while issues related to clinical safety and efficacy were not raised in the CRL, the FDA could not approve the NDA in its present form because questions still remained pertaining to Chemistry, Manufacturing and Controls (CMC).  

“Obviously, we are very surprised and disappointed [ … ] We believe the comments and recommendations stated in the CRL are manageable and plan to fully cooperate with the FDA,” said Dr Dennis J Carlo, President and CEO of Adamis. “Will will take the Agency’s suggestion and request a meeting as soon as possible to discuss our plan to resubmit the NDA.”

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Naloxone, an opioid antagonist, is used for the emergency treatment of known or suspected opioid overdose. Currently, naloxone is supplied in ampules and vials for IV, IM or SC administration, in a prefilled auto-injector, and as a nasal spray. According to recent case reports, higher doses of naloxone may be needed to reverse opioid overdoses resulting from carfentanil ingestion.

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