Adamis Pharmaceuticals provides an update on ZIMHI, high-dose naloxone injection product intended for the treatment of opioid overdose.

Adamis Pharmaceuticals Corporation provided an update on the status of the company’s New Drug Application (NDA) relating to its ZIMHI high-dose naloxone injection product intended for the treatment of opioid overdose. The company had a Type A meeting with the FDA to review comments on the additional information provided by the company in response to the FDA’s previous Complete Response Letter (CRL) regarding the NDA, and also to obtain input from the agency concerning the resubmission of the NDA. Adamis believes the meeting was productive and plans to resubmit the NDA for ZIMHI to the FDA within the next 45 days, absent unexpected delays. The FDA did not provide a detailed timeline for review but did indicate that it would attempt to work in an expeditious manner, acknowledging that the country is in an opioid crisis. Dr. Dennis J. Carlo, President and Chief Executive Officer of Adamis Pharmaceuticals, stated, “We believe we obtained critical feedback from the FDA at our Type A meeting on a number of issues and also received an acknowledgement of the agency’s intention to commit to a rapid review of the NDA. Currently, 88,000 deaths due to drug overdoses have occurred in a 12-month period ending in August 2020 and deaths have increased by 27% during the COVID-19 pandemic compared to the previous year. I believe the availability of our higher dose naloxone product could potentially save thousands of lives. In November 2020, the company received a CRL from the FDA regarding the NDA for Adamis’ ZIMHI high-dose naloxone injection product intended for the treatment of opioid overdose. Before the Type A meeting, the company provided responses to the issues that the FDA determined must be corrected before the agency can consider approving the NDA. .