Adamis Pharmaceuticals Provides an Update on ZIMHI™
Adamis Pharmaceuticals (NASDAQ: ADMP) provided an update regarding its New Drug Application (NDA) for ZIMHI™, a high-dose naloxone injection for opioid overdose treatment. Following a Type A meeting with the FDA, Adamis plans to resubmit the NDA within 45 days, pending no delays. The FDA indicated a commitment to expedite the review as the opioid crisis escalates. CEO Dr. Dennis J. Carlo highlighted the urgency, noting a significant rise in overdose deaths, emphasizing ZIMHI's potential to save lives.
- Planned resubmission of NDA for ZIMHI within 45 days.
- FDA acknowledged need for a rapid review process, reflecting the opioid crisis urgency.
- Previous Complete Response Letter (CRL) indicates regulatory challenges.
- No specific timeline provided by FDA for the resubmission review.
SAN DIEGO, April 12, 2021 (GLOBE NEWSWIRE) -- Adamis Pharmaceuticals Corporation (NASDAQ: ADMP) today provided an update on the status of the company’s New Drug Application (NDA) relating to its ZIMHI™ high-dose naloxone injection product intended for the treatment of opioid overdose. The company had a Type A meeting with the U.S. Food and Drug Administration (FDA) to review comments on the additional information provided by the company in response to the FDA’s previous Complete Response Letter (CRL) regarding the NDA, and also to obtain input from the agency concerning the resubmission of the NDA. Adamis believes the meeting was productive and plans to resubmit the NDA for ZIMHI to the FDA within the next 45 days, absent unexpected delays. The FDA did not provide a detailed timeline for review but did indicate that it would attempt to work in an expeditious manner, acknowledging that the country is in an opioid crisis.
Dr. Dennis J. Carlo, President and Chief Executive Officer of Adamis Pharmaceuticals, stated, “We believe we obtained critical feedback from the FDA at our Type A meeting on a number of issues and also received an acknowledgement of the agency’s intention to commit to a rapid review of the NDA. Currently, 88,000 deaths due to drug overdoses have occurred in a 12-month period ending in August 2020 and deaths have increased by
In November 2020, the company received a CRL from the FDA regarding the NDA for Adamis’ ZIMHI high-dose naloxone injection product intended for the treatment of opioid overdose. Before the Type A meeting, the company provided responses to the issues that the FDA determined must be corrected before the agency can consider approving the NDA.
About ZIMHI
ZIMHI is a high-dose naloxone injection product candidate intended for the treatment of opioid overdose. Naloxone is an opioid antagonist and is generally considered the drug of choice for immediate administration for opioid overdose. It works by blocking or reversing 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 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.
About Adamis Pharmaceuticals
Adamis Pharmaceuticals Corporation is a specialty biopharmaceutical company primarily focused on developing and commercializing products in various therapeutic areas, including allergy, opioid overdose, respiratory and inflammatory disease. The company’s SYMJEPI™ (epinephrine) Injection products are approved by the FDA for use in the emergency treatment of acute allergic reactions, including anaphylaxis. Adamis’ naloxone injection product candidate, ZIMHI™, for the treatment of opioid overdose, is currently under FDA review. Adamis is developing additional products, including treatments for acute respiratory diseases, such as COVID-19. The company’s subsidiary, US Compounding Inc., compounds sterile prescription drugs, and certain nonsterile drugs for human and veterinary use by hospitals, clinics, surgery centers, and vet clinics throughout most of the United States. For additional information about Adamis Pharmaceuticals, please visit www.adamispharmaceuticals.com.
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 its ability to satisfactorily respond to the matters raised in the FDA’s CRL; the company’s beliefs concerning the information, data and actions that the FDA may require in connection with any resubmitted New Drug Application (NDA) relating to ZIMHI; the company’s beliefs concerning the timing and outcome of any appeal or formal dispute resolution process that the company may initiate relating to the agency’s decisions regarding the NDA; the company’s beliefs concerning the results of any future studies or clinical trials that the company may conduct relating to ZIMHI; the company’s beliefs concerning the timing and outcome of the FDA’s review of the company’s NDA relating to the ZIMHI product or any resubmitted NDA; the company’s beliefs concerning its ability to commercialize ZIMHI and its other products and product candidates; the company's beliefs concerning the ability of its product candidates to compete successfully in the market; the company's beliefs concerning the safety and effectiveness of ZIMHI or its other products and product candidates; the company’s beliefs concerning its commercialization strategies; and the company’s beliefs concerning the anticipated timing of any commercial launch of its ZIMHI product. These statements are only predictions and involve known and unknown risks, uncertainties and other factors, which may cause Adamis' actual results to be materially different from these forward-looking statements. The FDA may require additional studies, or other actions, data or information, prior to any decision regarding a resubmitted NDA or after review of a resubmitted NDA. There can be no assurances that the company will be able to satisfactorily respond to the matters raised in the FDA’s CRL or concerning the timing of any resubmission by us of the NDA responding to the CRL, concerning the timing or costs of any additional actions that may be required in connection with any resubmission of the NDA, that the FDA will approve any resubmitted NDA relating to our ZIMHI product or concerning the timing of any future action by the FDA on our NDA, that the company will be successful in any formal dispute resolution appeal process with the FDA, or that the product will be able to compete successfully in the market if approved and launched. The FDA could issue an additional CRL or require additional studies, or other actions, data or information, following review or any resubmitted NDA. In addition, forward-looking statements concerning our anticipated future activities assume that we have 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, uncertainties, and other factors are described in greater detail in Adamis’ filings from time to time 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. Except to the extent required by law, any forward-looking statements in this press release speak only as the date of this press release, and Adamis expressly disclaims any obligation to update any forward-looking statements.
Contacts:
Investor Relations
Adamis Pharmaceuticals Corporation
IR@adamispharma.com
Robert Uhl
Managing Director, Westwicke ICR
619.228.5886, robert.uhl@westwicke.com
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