Adamis Pharmaceuticals Announces Publication Demonstrating PET Scan Results of Higher Dose Naloxone in Monkeys

Adamis Pharmaceuticals Corporation (NASDAQ: ADMP) (“Adamis”) announced publication in the peer reviewed journal Molecules, “The Effects of Intramuscular Naloxone Dose on Mu Receptor Displacement of Carfentanil in Rhesus Monkeys” (https://www.mdpi.com/1420-3049/25/6/1360). 

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 University of Michigan and was funded by Adamis Pharmaceuticals.

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).

Dr. Dennis J. Carlo, President and Chief Executive Officer of Adamis commented: “We are pleased to see these published study results support the use of a higher dose naloxone product, such as the one we are developing. We believe our ZIMHI naloxone injection could fill a void that currently exists in treating overdoses that result from more potent synthetic opioids. In the midst of the present COVID-19 pandemic, the need for a higher dose naloxone product may be greater than ever before. Adamis remains on track for re-submitting our New Drug Application for our ZIMHI product candidate in the second quarter of 2020 and is currently in late stage partnering discussions.”

About ZIMHI

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 (CDC) in 2017, drug overdoses resulted in approximately 72,000 deaths in the United States – greater than 195 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.

About Adamis Pharmaceuticals

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 U.S. in July 2019. Please refer to www.SYMJEPI.com for additional product information. In addition to its ZIMHI (naloxone) injection product, Adamis is developing other products, including a metered dose inhaler and dry powder inhaler product candidates for the treatment of asthma and COPD. The company’s subsidiary, U.S. Compounding, Inc., compounds sterile prescription drugs, and certain nonsterile drugs for patients, animals, hospitals, clinics and surgery centers throughout most of the United States.

Adamis Forward Looking Statements

This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. Such forward-looking statements include those that express plans, anticipation, intent, contingencies, goals, targets or future development and/or otherwise are not statements of historical fact. These statements are only predictions and involve known and unknown risks, uncertainties and other factors, which may cause Adamis' actual results to be materially different from these forward-looking statements. In addition, forward-looking statements concerning our anticipated future activities assume that we are able to obtain sufficient funding to support such activities and continue our operations and planned activities. As discussed in our filings with the Securities and Exchange Commission, we may require additional funding, and there are no assurances that such funding will be available if required. You should not place undue reliance on any forward-looking statements. Further, any forward-looking statement speaks only as of the date on which it is made, and except as may be required by applicable law, we undertake no obligation to update or release publicly the results of any revisions to these forward-looking statements or to reflect events or circumstances arising after the date of this press release. Certain of these risks, uncertainties, and other factors are described in greater detail in Adamis’ filings from time to time with the SEC, which Adamis strongly urges you to read and consider, all of which are available free of charge on the SEC's web site at http://www.sec.gov. Except to the extent required by law, any forward-looking statements in this press release speak only as the date of this press release, and Adamis expressly disclaims any obligation to update any forward-looking statements.

Contact Adamis: Mark Flather Senior Director, Investor Relations& Corporate Communications (858) [e-mail]