Adamis Pharmaceuticals Announces Publication of Pharmacokinetic model suggesting that higher doses of naloxone are needed for successful resuscitation due to fentanyl overdose

SAN DIEGO, June 18, 2020 (GLOBE NEWSWIRE) -- Adamis Pharmaceuticals Corporation (NASDAQ: ADMP) (“Adamis”) announced today the publication of an article entitled “Higher naloxone dosing in a quantitative systems pharmacology model that predicts naloxone-fentanyl competition at the opioid mu receptor level” in the peer reviewed publication “PLOS ONE, ” This study was done in collaboration with Rosa and Co.

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. Rapid resuscitation of an opioid overdose with naloxone, an opioid antagonist, is critical as opioid induced toxicity results in rapid death, i.e., delaying adequate resuscitation can result in death.  Accordingly, the current approved naloxone doses (2 mg intramuscular (IM) and 4 mg intranasal (IN)), since they both give similar systemic exposure levels, might very well not be sufficient to reverse high doses of fentanyl. Fentanyl, a synthetic opioid, is considered 50 to 100 times more potent than morphine. According to the CDC, powerful synthetic opioids, like fentanyl and its analogues, are responsible for the largest number of deaths from opioid overdoses.  To this end, it was recently reported that drug overdoses in British Columbia last month killed more people there than COVID-19 has all year.  The vast majority of the overdose deaths involved fentanyl.  There is no reason to believe that this same trend is not happening in the U.S.

The manuscript describes an opioid receptor quantitative systems pharmacology (QSP) model which was developed to predict the effects of different IM doses of naloxone ( 2 mg, 5 mg, and 10 mg) in response to different levels of fentanyl exposure (low, medium, and high). The model defined a successful reversal as lowering the amount of opioid bound to the brain receptors to less than 50% within 10 minutes. For the lowest and middle levels of fentanyl exposure, the model predicted that the 2 mg IM naloxone resulted in successful resuscitations within ten minutes, but more rapid reversal was observed with the 5 and 10 mg doses. However, at the highest level of naloxone exposure, the model predicted that the 2 mg IM (and 4 mg IN) doses of naloxone did not result in a successful reversal. In contrast, the 5 and 10 mg doses of naloxone successfully reversed opioid toxicity.

Dr. Dennis J. Carlo, President and CEO of Adamis, stated, “These results suggest that the current marketed doses of naloxone (2 mg IM or 4 mg IN) may be inadequate for rapid reversal of toxicity due to fentanyl exposure and that increasing the dose of naloxone is likely to improve outcomes. Therefore, it is reasonable to conclude that our high dose (5 mg IM) naloxone product candidate (ZIMHI) has the potential to improve outcomes and save lives.”  

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 were approved by the FDA for use in the emergency treatment of acute allergic reactions, including anaphylaxis.  On May 11^th the Company announced a partnership with US WOLRD MEDS for the commercialization of ZIMHI and SYMJEPI. The company’s subsidiary, U.S. Compounding, Inc., compounds sterile prescription drugs for human and veterinary use, and certain nonsterile drugs for use by 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 relate to future events or future results of operations, including, but not limited to the following statements: the company’s beliefs concerning the timing and outcome of the FDA’s review of the company’s New Drug Application (NDA) relating to its ZIMHI™ (naloxone) Injection product candidate; the data and interpretation of the data from the company’s studies pertaining to the ZIMHI product candidate; the company’s ability to  commercialize its product and product candidates, itself or through commercialization partners; the company’s beliefs concerning the ability of its products and product candidates to compete successfully in the market; the company’s beliefs concerning the safety and effectiveness of ZIMHI and its other products and product candidates; and other statements concerning our future operations and activities.  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, are not guarantees, involve known and unknown risks, uncertainties and other factors, and concern matters that could subsequently differ materially from those described in this press release, which may cause Adamis' actual results to be materially different from those contemplated by these forward-looking statements.  There can be no assurances regarding the timing or the outcome of the FDA’s review process concerning the company’s NDA relating to ZIMHI.  There can be no assurances that the FDA will agree with our interpretation of study data, will approve our NDA relating to our naloxone product candidate or will give final approval to our proposed brand name for the product, concerning the timing of any such approval, that the product will be commercially successful if approved and introduced, or concerning the outcome of any discussions with third parties concerning commercialization of the product.  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.  We cannot assess the impact of each factor on our business or the extent to which any factor, or combination of factors, may cause actual results to differ materially from those contained in any forward-looking statements.  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, and additional risks, uncertainties, and other factors are described in greater detail in Adamis’ filings from time to time with the SEC, including its annual report on Form 10-K for the year ended December 31, 2019, and our subsequent filings 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.

Contacts:

Mark Flather
Senior Director, Investor Relations
& Corporate Communications
Adamis Pharmaceuticals Corporation
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