SAN DIEGO, May 14, 2019 — Adamis Pharmaceuticals Corporation (NASDAQ: ADMP) announced today conditional acceptance by the U.S. Food and Drug Administration (FDA) of the proposed brand name for the company’s high dose naloxone product candidate. The notification to the company from the FDA noted that after review, the proposed proprietary name “Zimhi™” was conditionally acceptable.
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, in 2017, drug overdoses resulted in approximately 70,000 deaths in the United States – nearly 200 deaths per day. Drug overdoses are now the leading cause of death for Americans under 50, and the proliferation of more powerful synthetic opioids, such as fentanyl and its analogues, could result in future increases in the number of deaths resulting from opioid overdoses. Based on the current opioid epidemic, particularly involving the more potent fentanyl narcotics, we and others have published reports supporting the need for a higher dose naloxone product (https://substanceabusepolicy.biomedcentral.com/articles/10.1186/s13011-019-0195-4) such as Zimhi.
In December 2018, the joint meeting of the Anesthetic and Analgesic Products Advisory Committee and the Drug Safety and Risk Management Advisory Committee voted in favor of adding labeling language that recommends co-prescription of naloxone for all or some patients prescribed opioids. Medicare (HHS) has also recommended co-prescribing naloxone with opioids under certain conditions. These recommendations could significantly increase the naloxone market.
As announced in December 2018, the company filed a New Drug Application (NDA) relating to its higher dose naloxone injection product for the treatment of opioid overdose. On March 14, 2019, the company received notice from the FDA that it had determined the NDA was sufficiently complete to permit a substantive review, and the agency provided a target agency action date of October 31, 2019. Final approval of the brand name is conditional on FDA approval of the company’s NDA. The company is currently exploring commercialization options for the Naloxone product and is engaged in discussions with potential commercialization and marketing partners.
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 SYMJEPI (epinephrine) Injection 0.15mg products are FDA approved for use in the emergency treatment of acute allergic reactions, including anaphylaxis. 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, and deaths due to fentanyl and other opioids; use of naloxone to help treat opioid overdoses; the potential for future growth in the naloxone market; the company’s beliefs concerning the timing and outcome of the FDA’s review of the company’s NDA relating to its naloxone product candidate and its review of the proposed brand name for the product; the company’s ability to successfully develop its naloxone product candidate and other product candidates; and the outcome of any discussions with third parties concerning commercialization of the product. 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 that the FDA 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 could request additional or different submissions or request additional data, information, materials or clinical trials or studies, all of which could affect the timing and outcome of the review process. As a result, there can be no assurances regarding the timing or the outcome of the FDA’s review process. 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 most recent annual report on Form 10-K 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