Adamis Provides Update on ZIMHI™

Rhea-AI Summary

Adamis Pharmaceuticals Corporation announced the FDA's acceptance of its resubmitted New Drug Application (NDA) for ZIMHI, a higher naloxone injection aimed at treating opioid overdose. The FDA deems the application complete and has set a target action date of November 12, 2021. This decision highlights the increasing need for effective treatment alternatives amid the rising opioid crisis, which has seen overdose deaths soar by over five times since 1999. Adamis aims to work closely with the FDA to foster ZIMHI’s approval and commercialization.

Positive

• FDA accepted NDA for ZIMHI for opioid overdose treatment.
• Target action date set for November 12, 2021.

Negative

• None.

FDA Deems New Drug Application for ZIMHI Complete and Establishes a Target Action Date of November 12, 2021

SAN DIEGO, June 09, 2021 (GLOBE NEWSWIRE) -- Adamis Pharmaceuticals Corporation (NASDAQ: ADMP) today announced that the U.S. Food and Drug Administration (FDA) has accepted for review the Company’s resubmitted New Drug Application (NDA) for ZIMHI™, which is its higher naloxone injection product candidate for the treatment of opioid overdose. Adamis received FDA correspondence relating to the Company’s NDA, stating that the Agency had completed its filing review and had determined that the NDA was sufficiently complete to permit a substantive review. The FDA also provided a target action date under the Prescription Drug User Fee Act (PDUFA date) of November 12, 2021.

“We are pleased with the FDA’s decision to accept for review our NDA for ZIMHI. I believe this underscores the need for additional treatment alternatives for narcotic overdose,” said Dr. Dennis J. Carlo, President and Chief Executive Officer of Adamis Pharmaceuticals. “We look forward to working collaboratively with the FDA during the review process to support the case for approval of ZIMHI.”

About Naloxone and the Growing Crisis of Opioid Overdose

• Naloxone is an opioid antagonist used to treat narcotic overdoses and is generally considered the treatment of choice for immediate administration in instances of opioid overdose.
  
  
• Naloxone blocks or reverses effects of the opioid, including extreme drowsiness, slowed breathing and loss of consciousness.
  
  
• Common opioids include morphine, heroin, tramadol, oxycodone, hydrocodone and fentanyl.

• The number of deaths due to opioids has increased over 5X since 1999. According to statistics published by the Centers for Disease Control and Prevention.
  
  
  • In the 12 months ending May 2020, drug overdoses resulted in approximately 81,000 deaths in the United States – greater than approximately 220 deaths per day.
    
    
  • Drug overdoses are now the leading cause of death for Americans under 50.
    
    
  • 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.
    

Recent studies from 2013 to 2016 have revealed an approximately 87% increase in deaths associated with synthetic opioids, whereas death rates due to natural and semisynthetic opioids remained relatively stable. In response to this significant increase in synthetic opioid abuse, there have been published studies that suggest the current recommended doses of naloxone may be inadequate and frequent redosing is likely required. Repeat dosing of the commonly utilized dose of naloxone suggests the need for a higher dosage product.

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. (USC), 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.

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 regarding the timing or outcome of our resubmission of the NDA to the FDA or the FDA’s review of the resubmitted NDA relating to the ZIMHI product, whether the FDA will regard the resubmitted NDA as satisfactory, whether the FDA will require additional actions, information or trials after review of a resubmitted NDA or issue another CRL, or the timing, costs or outcome of any additional actions that may be required following any resubmission of the NDA, or that the product will be able to compete successfully in the market if approved and launched. the Company’s beliefs concerning the safety and effectiveness of ZIMHI or the Company’s other product candidates; the Company’s ability to commercialize the product candidates described in this press release, itself or through commercialization partners; the Company’s beliefs concerning the benefits, enforceability, and extent of intellectual property protection afforded by patents and patent applications that it owns or has licensed, and its ability to enforce its patents and other intellectual property rights against third parties; and other statements concerning our future operations and activities. 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 the results anticipated by such forward-looking statements. 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, 2020 and 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.

Contact:

Adamis Investor Relations
Robert Uhl
Managing Director
Westwicke ICR
619.228.5886
robert.uhl@westwicke.com

FAQ

What is the significance of the FDA's acceptance of ADMP's NDA for ZIMHI?

The FDA's acceptance signifies a crucial step toward potential approval of ZIMHI, addressing the urgent need for effective opioid overdose treatments.

When is the target action date for the ZIMHI NDA?

The target action date for the ZIMHI NDA is November 12, 2021.

How has the opioid crisis impacted the need for naloxone products like ZIMHI?

The opioid crisis has led to a dramatic increase in overdose deaths, underscoring the demand for more effective naloxone treatments, such as ZIMHI.