The CRL stated that the FDA determined it cannot approve the NDA in its present form and provided recommendations needed for resubmission.
A CRL is issued by the FDA's Center for Drug Evaluation and Research when it has completed its review of a file and questions remain that preclude the approval of the NDA in its current form. The questions raised by the FDA related generally to new Chemistry, Manufacturing and Controls (CMC) issues. It should be noted that no issues related to "extractables and leechables testing", that were associated with the previous initial CRL that the company received relating to the product, were noted by the FDA. The company's plan is to provide the FDA with additional analysis and information in order to attempt to satisfy the CRL items. The company will request a Type A meeting or consider other options to resolve the issues.
Dr. Dennis J. Carlo, President and CEO of Adamis, stated, "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. 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. With all of the factors that are currently contributing to a growing number of fatal overdoses during the COVID-19 pandemic, we believe there is a clear need for higher dose forms of intramuscular naloxone found in ZIMHI. We remain committed to this product and our mission to provide physicians and patients access to a higher dose of naloxone. As soon as reasonably possible, we will resubmit additional information and analysis of data to the FDA for the NDA."