Naloxone is an opioid antagonist that binds the opioid receptors in the brain (mu receptors) and displaces opioid-bound drugs thereby reversing toxicity and resuscitating an overdose victim. However, we and others believe that a higher dose of naloxone is required to resuscitate an opioid overdose caused by more potent synthetic opioids. In this study, monkeys received doses of carfentanil, a synthetic opioid 10,000 times stronger than morphine and 100 times more potent than fentanyl, followed by different doses of naloxone. The monkeys were then examined using PET (Positron Emission Tomography) imaging of the brain to observe the number of brain receptors bound with naloxone. The study found that higher doses of naloxone resulted in an increased number of naloxone-bound brain receptors, thereby lowering the number of brain receptors bound with the opioid. A higher level of naloxone, similar to levels produced by Adamis’ ZIMHI™ product candidate, displaced more carfentanil bound to receptors compared to lower naloxone levels typically observed with current lower dose marketed naloxone products. The authors concluded that “the results suggest that higher doses of IM naloxone result in higher receptor occupancy and could be useful in combating overdoses resulting from potent synthetic opioids”. The study was conducted by researchers at the
Prior to the COVID19 outbreak, accidental overdoses were already the leading cause of death among Americans under 50, and there is now concern that one indirect effect of the pandemic will be an increase in overdose deaths (https://abcnews.go.com/US/officials-worry-potential-spike-overdose-deaths-amid-covid/story?id=70149746) (https://www.politico.com/news/2020/04/10/trump-officials-health-experts-worry-coronavirus-will-set-back-opioid-fight-179257).
ZIMHI is a high-dose naloxone injection product candidate intended for the treatment of opioid overdose. Naloxone is an opioid antagonist and is generally considered the drug of choice for immediate administration for opioid overdose. It works by blocking or reversing the effects of the opioid, including extreme drowsiness, slowed breathing, or loss of consciousness. Common opioids include morphine, heroin, tramadol, oxycodone, hydrocodone and fentanyl. According to statistics published by the Centers for Disease Control and Prevention (
Adamis Pharmaceuticals Corporation is a specialty biopharmaceutical company primarily focused on developing and commercializing products in various therapeutic areas, including respiratory disease, allergy and opioid overdose. The company’s SYMJEPI (epinephrine) Injection 0.3mg and SYMJEPI (epinephrine) Injection 0.15mg products both use the same injection device as used for ZIMHI and were approved by the FDA for use in the emergency treatment of acute allergic reactions, including anaphylaxis, and both were fully launched in the
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Source: Adamis Pharmaceuticals Corporation