Adamis Pharmaceuticals Resubmits ZIMHI New Drug Application to FDA for the Treatment of Opioid Overdose
Adamis Pharmaceuticals Corporation (NASDAQ: ADMP) has resubmitted its New Drug Application (NDA) for ZIMHI™, a high-dose naloxone injection intended for opioid overdose treatment, to the FDA. This follows feedback from a Type A meeting held in April. The CEO, Dr. Dennis J. Carlo, expressed confidence that the new submission addresses previous concerns raised in a November 2020 Complete Response Letter. ZIMHI aims to provide an effective alternative in the market for naloxone products, potentially saving lives during the ongoing opioid crisis.
- Resubmission of NDA for ZIMHI addresses FDA's previous concerns.
- ZIMHI aims to provide a high-dose alternative for opioid overdose treatment.
- Risks associated with regulatory approval process for ZIMHI remain.
- No guarantee of successful commercialization post-approval.
SAN DIEGO, May 17, 2021 (GLOBE NEWSWIRE) -- Adamis Pharmaceuticals Corporation (NASDAQ: ADMP), a biopharmaceutical company developing and commercializing specialty products for respiratory disease, allergy and opioid overdose, today announced that the New Drug Application (NDA) was resubmitted to the U.S. Food and Drug Administration (FDA) for ZIMHI™, a naloxone injection product candidate intended for the treatment of opioid overdose.
“Based on FDA feedback received during our Type A meeting in April, we have resubmitted our NDA for ZIMHI, which I am confident fully addresses the issues raised in the November 13, 2020 Complete Response Letter,” said Dr. Dennis J. Carlo, President and Chief Executive Officer of Adamis Pharmaceuticals. “We are committed to working collaboratively with the agency as it conducts its review of the resubmitted NDA. I continue to believe the availability of additional naloxone products, especially our higher dose intramuscular injection product, which has definite advantages over the two approved intranasal products, could potentially save thousands of lives.”
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, influenza, asthma, and COPD. 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 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 whether it has satisfactorily responded to the matters raised in the FDA’s Complete Response Letter (CRL); the company’s beliefs concerning the information, data and actions that the FDA may require in connection with the resubmitted New Drug Application (NDA) 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; 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 resubmission of the NDA. There can be no assurances that the company will be able to satisfactorily respond to the matters raised in the FDA’s CRL, 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, or that the product will be able to compete successfully in the market if approved and launched. 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.
Contact:
Adamis Investor Relations
Robert Uhl
Managing Director
Westwicke ICR
619.228.5886
robert.uhl@westwicke.com
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