Adamis plans to address agency concerns regarding the naloxone injection application.
The US Food and Drug Administration (FDA) has issued a Complete Response Letter (CRL) for an application for a high dose naloxone (ZIMHI) injection product for the treatment of opioid overdoses.
In the CRL, the agency has recommended Adamis Pharmaceuticals Corporation resubmit an application for the treatment while addressing questions related to new Chemistry, Manufacturing, and Controls (CMC) issues.
The FDA did not find any problems related to extractables and leechables issues, which were associated with a previous CRL issued for the same product. Adamis has indicated they plan to provide the FDA with additional data in an attempt to satisfy the letter. The pharmaceutical company also plans to request a Type A meeting or present alternative options in order to resolve the issues.
“This is a very disappointing setback that was totally unexpected since we completed the extractables and leechables issues that were associated with the first CRL,” Dennis J. Carlo MD, President and CEO of Adamis, said in a statement. “To me, it is very surprising to have new issues brought up this late in the review process. We believe the comments and recommendations stated in the CRL can be addressed and overcome.”
Naloxone is an opioid antagonist that is considered the choice option for the immediate administration for opioid overdoses. The drug works by blocking or reversing the effects of the opioid, including extreme drowsiness, slowed breathing, or loss of consciousness.