SAN DIEGO, Feb. 20, 2019 — Adamis Pharmaceuticals Corporation (NASDAQ: ADMP) (“Adamis”) announced today that the article entitled “Higher doses of naloxone are needed in the synthetic opioid era” has been published in the peer reviewed journal Substance Abuse Treatment, Prevention, and Policy. (https://substanceabusepolicy.biomedcentral.com/articles/10.1186/s13011-019-0195-4)
The article notes the dramatic increase in deaths due to illicit use of the opioid fentanyl, reviews the literature on the number of repeat doses of naloxone to treat fentanyl overdoses, reviews the pharmacology of naloxone and fentanyl, and provides a rationale for using higher doses of naloxone as an effective countermeasure. The authors conclude that “administering higher doses of naloxone may be a simple countermeasure that can be initiated rapidly in an attempt to lower morbidity and mortality in the new opioid era”.
Naloxone is an opioid antagonist used to treat narcotic overdoses. Naloxone, which is generally considered the drug of choice for immediate administration for opioid overdose, blocks or reverses 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 the proliferation of more powerful synthetic opioids, like fentanyl and its analogues, could result in future increases in the number of deaths resulting from opioid overdoses. The current epidemic of drug overdoses is killing people at a faster rate than the HIV epidemic at its peak.
Ronald Moss, MD, Chief Medical Officer at Adamis, commented on the publication: “The dramatic rise in deaths due to fentanyl and other opioids is an unprecedented major public health concern as evidenced by the data from the CDC as well as by the Surgeon General requesting expansion of naloxone use. Higher doses of naloxone could be useful in cases of fentanyl overdoes for self or layperson administration.”
“This article provides a rationale for the higher dose naloxone product that we are developing”, said Dr. Dennis J. Carlo, President and CEO of Adamis. “The need for multiple doses of naloxone to help combat fentanyl related opioid overdoses may support the need for higher doses of naloxone for overdose reversal. We are hoping that we can be part of the solution for this devastating epidemic and look forward to working with the FDA and others with regard to our higher dose product candidate.”
Adamis’ naloxone product candidate uses a similar pre-filled syringe injection platform as is used in its FDA-approved Symjepi product for treatment of allergic reactions (Type I) including anaphylaxis. Human factors studies to date using the small, intuitive Symjepi device demonstrate the ease of using of Symjepi in several user groups including untrained adolescents aged 12 to 17 years old. Adamis submitted a New Drug Application for its high dose naloxone product candidate to the U.S. Food and Drug Administration on December 31, 2018.
Adamis Pharmaceuticals Corporation is a specialty biopharmaceutical company primarily focused on developing and commercializing products in various therapeutic areas, including respiratory disease and allergy. The company’s Symjepi (epinephrine) Injection 0.3mg and 0.15mg products are FDA approved for use in the emergency treatment of acute allergic reactions, including anaphylaxis. Adamis is developing naloxone and sublingual tadalafil product candidates as well as additional product candidates using its approved injection device, and a metered dose inhaler and dry powder inhaler devices. The company’s subsidiary, U.S. Compounding, Inc., compounds sterile prescription drugs, and certain nonsterile drugs for human and veterinary use, to patients, physician clinics, hospitals, surgery centers and other clients 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 drug overdoses in the United States, illicit use of opioids in the United States, deaths due to fentanyl and other opioids, use of naloxone to help treat opioid overdoses, the use of repeat doses of naloxone to treat fentanyl overdoses, the pharmacology of naloxone and fentanyl the rationale for using higher doses of naloxone as an effective countermeasure, the company’s naloxone product candidate, the company’s other product candidates, and the company’s ability to successfully develop its naloxone product candidates and other product candidates. 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. 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, 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, 2017, 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