FDA rejects Adamis Pharma's opioid overdose candidate NDA

USA-based Adamis Pharmaceuticals (Nasdaq: ADMP) yesterday revealed that, after the close of US markets on November 22, it received a Complete Response Letter (CRL) from the US Food and Drug Administration regarding its New Drug Application (NDA) for Zimhi, a 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, with the news sending the firm’s shares plummeting 61% to $0.49 in pre-market trading and closing the day down 51% at $0.62.

The questions raised by the FDA related generally to Chemistry, Manufacturing and Controls (CMC). The plan is to expand on the CMC testing that has already been provided to the FDA to satisfy the CRL items. No other clinical safety or efficacy issues were raised, and the New Drug Application will remain open until the CMC issues are resolved.