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 Cmax (maximum concentration), AUC (area under the curve), and t1/2 (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 Cmax 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.
“We have recently resubmitted our NDA to the FDA for our higher dose naloxone product ZIMHI and are hopeful for a rapid review. Of note, there have been concerns raised about increased opioid related deaths indirectly due to COVID-19. We will continue to work with the FDA and our new partner, US WorldMeds, to commercialize ZIMHI, as we believe it can make a difference in the public health response to the opioid epidemic,” said Dr. Dennis J. Carlo, President and Chief Executive Officer of Adamis.
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 11th the Company announced a partnership with US WorldMeds 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 results of the study referenced in the press release and the interpretation of the data from the study; 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.