CMC Questions Lead to Complete Response Letter for Opioid Addiction Treatment

Adamis Pharmaceuticals’ was hit with a complete response letter for its opioid overdose treatment Zimhi (naloxone).

The CRL explained that the agency could not approve the NDA for the high-dose naloxone injection in its current form because questions remained over its chemistry, manufacturing and controls.

Adamis said that no clinical safety or efficacy issues were raised and the NDA will remain open until the CMC issues are resolved.