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SAN DIEGO, Oct. 08, 2019 (GLOBE NEWSWIRE) -- Adamis Pharmaceuticals Corporation (NASDAQ: ADMP) (“Adamis”) announced today the presentation of data pertaining to its investigational high dose naloxone product (ZIMHI) at the Institute of Human Virology (IHV) meeting (http://www.ihv.org/ihvmeeting/Program/) in a session on “Opioid Intersection”. Other participants at the meeting included Dr. Robert Gallo, Co-Founder and Director, Institute of Human Virology, Dr. Nora Volkow, Director, National Institute of Drug Abuse, National Institutes of Health, and Admiral Brett Giroir, MD, Assistant Secretary for Health, US Department of Health and Human Services. The Adamis data was presented by Dr. Ronald Moss, Chief Medical Officer at Adamis.
Naloxone is an opioid antagonist that competes opioids off their receptors in the brain. Rapid and efficient reversal by naloxone is critical as brain injury and death can occur within minutes.
Adamis presented data comparing the pharmacokinetics of ZIMHI to current doses of naloxone products (Evzio, Narcan, and generic Naloxone). ZIMHI had significantly higher and more rapid levels of naloxone in the blood compared to the other products.
Adamis also presented data on a model that simulated various overdoses due to the more potent synthetic opioids such as fentanyl. ZIMHI was shown in the model to rapidly compete out fentanyl from the receptors in the brain while current doses took longer. The model suggested that at higher doses of fentanyl overdose, higher doses of naloxone, such as are contained in ZIMHI, can potentially result in a more rapid and successful resuscitation.
Dr. Dennis J. Carlo, President and CEO of Adamis commented on the presentation: “We believe these data suggest that ZIMHI should be useful in the current opioid epidemic, where the more potent synthetic opioids continue to cause deaths. We are hopeful that if our ZIMHI product candidate is approved and commercialized, both patients and first responders will have access to a higher dose naloxone product, which should lead to saving more 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, and both were fully launched in the U.S. in July 2019. Please refer to www.SYMJEPI.com for additional product information. Adamis is developing additional products, including a naloxone injection product candidate, ZIMHI, for the treatment of opioid overdose, and 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. 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 NDA relating to its ZIMHI™ (naloxone) Injection product candidate; the data and interpretation of the data from the company’s studies pertaining to the company’s 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 its 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. 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. The FDA review process is subject to a number of uncertainties. The FDA’s review processes can extend beyond, and in some cases significantly beyond, anticipated target PDUFA action dates due to the timing of the FDA’s review process, FDA requests for additional data, information, materials or clarification, difficulties scheduling an advisory committee meeting, FDA workload issues, extensions resulting from the submission of additional information or clarification regarding information already in the submission within the last three months of the target PDUFA date, such as submission of the results of the company’s PK study, or other reasons. As a result, the dates of regulatory approval, if obtained, and commercial introduction of our product could be delayed beyond our expectations. 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, 2018, 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.
Senior Director, Investor Relations
& Corporate Communications
Adamis Pharmaceuticals Corporation