Adamis Pharmaceuticals Describes Planned Response to ZIMHI Complete Response Letter
02 December 2020 - 1:00AM
Adamis Pharmaceuticals Corporation (NASDAQ: ADMP) today
announced a planned response to a Complete Response Letter (CRL)
from the U.S. Food and Drug Administration (FDA),
regarding its New Drug Application (NDA) for Adamis’ ZIMHI™ high
dose naloxone injection product for the treatment of opioid
overdose.
The CRL, received November 13, 2020, identified deficiencies
that the FDA determined must be corrected before the Agency can
approve the NDA, and provided recommendations needed for
resubmission. FDA had not previously identified those deficiencies.
Adamis intends to address all the deficiencies raised in the CRL
and request that FDA approve the NDA. All of the company’s
responses to the deficiencies will be submitted before year end.
The company will then ask the FDA for a Type A meeting. If the
matter cannot be resolved with the FDA Division that sent the CRL,
Adamis intends to appeal the matter within the agency through a
Formal Dispute Resolution.
Dr. Dennis J. Carlo, President and Chief Executive Officer of
Adamis Pharmaceuticals, stated, “We believe our high dose naloxone
product (ZIMHI) offers a greater possibility to save lives given
the high rates of synthetic opioid (fentanyl) overdoses. As the
COVID-19 pandemic increases, the number of deaths due to opioid
overdoses has also risen. Currently, only lower dose naloxone
products are available. Recently, the injectable Evzio products
have been discontinued, leaving no available intramuscular products
approved for the layperson. This leaves a therapeutic vacuum that
our high dose product would automatically fill and 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. In addition to its ZIMHI,
naloxone injection product candidate, Adamis is developing
additional products, including treatments for acute respiratory
diseases, such as COVID-19, influenza, asthma and COPD. The
company’s subsidiary, U.S. 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.
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 and formal dispute
resolution process that the company may initiate; 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 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 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. 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 will 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:
Mark FlatherSenior Director, Investor Relations& Corporate
CommunicationsAdamis Pharmaceuticals Corporation(858)
412-7951mflather@adamispharma.com
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