Adamis Pharmaceuticals to Fund ZIMHI Clinical Study with University of Leiden Opioid Expert

SAN DIEGO, July 28, 2023 (GLOBE NEWSWIRE) -- Adamis Pharmaceuticals Corporation (NASDAQ: ADMP), a commercial-stage biopharmaceutical company, today announced the Company has committed to fund an unrestricted research grant to the Leiden University Medical Center (LUMC) Anesthesia and Pain Research Unit. The funding will support the work of Albert Dahan, MD, PhD, a world expert on opioid-induced respiratory depression (opioid overdose) and professor of anesthesiology at the University. Dr. Dahan has been working with the FDA since 2020 to understand better methods of reversing fentanyl overdoses.

“Data presented from our recent study conducted in collaboration with the U.S. Food and Drug Administration (FDA) indicated that faster and higher blood concentrations of naloxone are most effective in reversing overdoses from higher strength opioids, such as fentanyl,” said Dr. Dahan. “The objective of this collaboration with Adamis will be to assess the efficacy of 5mg intramuscular ZIMHI versus 4mg of intranasal naloxone, which is comparable to NARCAN and the respective number of doses required to reverse fentanyl-induced respiratory depression.”

The prior study data referenced above by Dr. Dahan was presented in a summary report released by the Reagan-Udall Foundation of the FDA in March, which states that, “The most recent rise in overdose deaths is primarily driven by fentanyl and fentanyl analogs.” The summary goes on to highlight that “higher naloxone doses (than the current standard of care) may be required for an initial reversal of respiratory depression due to fentanyl."¹

Eboo Versi, MD, PhD, CEO of Adamis, said, “These data from the FDA are supported by what we are hearing from first responders having to deal with fentanyl overdoses and poisoning, and this has resulted in tragic consequences.”

“Narcan is the standard of care to reverse an opioid overdose, but with fentanyl we are needing to use about three doses to achieve recovery,” said David B. Rausch, Director of the Tennessee Bureau of Investigation.

Samuel P. Chapman, Director of Parents for Safer Children, stated, “Prescription strength ZIMHI is the best remedy available for opioid overdose. If we had had some in the house when our son Sammy died, he would still be with us.”

“We believe that if ZIMHI demonstrates superiority in reversing fentanyl-induced respiratory depression in patients in the LUMC clinical study, national health organizations will update their emergency protocols to include the use of ZIMHI,” stated Dr. Versi. “Given the increased incidence of fentanyl poisoning, especially when combined with xylazine, there is now a need for a treatment that quickly results in high blood levels of naloxone as effected by ZIMHI. I believe that all first responders and harm reduction groups should have ZIMHI in their toolbox.”