Adamis Pharmaceuticals Announces Publication of Pharmacokinetic study comparing ZIMHI to current 2 mg intramuscular dose of naloxone

SAN DIEGO, May 27, 2020 (GLOBE NEWSWIRE) -- Adamis Pharmaceuticals Corporation (NASDAQ: ADMP) (“Adamis”) announced today the publication of an article entitled “An open-label, randomized, single-dose, two-period, two-treatment crossover bioavailability study comparing 5 mg/0.5 ml of intramuscular naloxone hydrochloride to 2 mg/0.4 ml intramuscular naloxone hydrochloride autoinjector in healthy subjects“ in the peer reviewed publication “The Journal of Opioid Management.”

The article compares the pharmacokinetics of the current intramuscular (IM) doses of naloxone (2 mg dose, Evzio, Kaleo Inc) to Adamis’ investigational drug ZIMHI (5 mg dose) in healthy subjects. The 5 mg dose of naloxone significantly increased pharmacokinetic parameters including C_max  (maximum concentration), AUC (area under the curve), and t_1/2 (biological half-life) compared to the 2 mg IM dose_. This equated to ZIMHI showing over three times the blood levels compared to the 2 mg IM dose for some parameters.  The authors concluded that “These results are consistent with the study rationale that indicated that higher doses of intramuscular naloxone hydrochloride would result in higher C_max and AUCs.  These PK characteristics may be desirable for reversing opioid toxicity caused by the higher more potent synthetic opioids.”

Naloxone is an opioid antagonist used to treat narcotic overdoses. Naloxone works by reversing the detrimental effects of the opioid, including slowed breathing, brain dysfunction, loss of consciousness and death. Common opioids include morphine, heroin, tramadol, oxycodone, hydrocodone and fentanyl.

According to statistics published by the Centers for Disease Control and Prevention (CDC) in 2018, drug overdoses resulted in approximately 67,000 deaths in the United States – greater than 185 deaths per day. Drug overdoses are now the leading cause of death for Americans under 50, and more powerful synthetic opioids, like fentanyl and its analogues, are responsible for the largest number of deaths from opioid overdoses. We and others believe that a higher dose naloxone is needed as a counter measure to successfully reverse opioids overdoses due to the more potent synthetic opioids.