Adamis Pharmaceuticals Resubmits ZIMHI New Drug Application to FDA for the Treatment of Opioid Overdose
May 17 2021 - 7:30AM
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 RelationsRobert UhlManaging DirectorWestwicke
ICR619.228.5886robert.uhl@westwicke.com
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