Adamis Pharmaceuticals receives a Complete Response Letter from the FDA regarding Zimhi for the treatment of opioid overdose.

Adamis Pharmaceuticals Corporation announced that after the close of business and the U.S. markets on November 13th, it received a Complete Response Letter (CRL) from the FDA regarding its New Drug Application (NDA) for Adamis’ Zimhi high dose naloxone injection product for the treatment of opioid overdose. 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.