Adamis Pharmaceuticals Receives a Complete Response Letter from the FDA Regarding ZIMHI
November 16 2020 - 6:45AM
Adamis Pharmaceuticals Corporation (NASDAQ: ADMP) (“Adamis”) today
announced that after the close of business and the U.S. markets on
November 13th, it received 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 stated that
the FDA determined it cannot approve the NDA in its present form
and provided recommendations needed for resubmission.
A CRL is issued by the FDA's Center for Drug Evaluation and
Research when it has completed its review of a file and questions
remain that preclude the approval of the NDA in its current form.
The questions raised by the FDA related generally to new
Chemistry, Manufacturing and Controls (CMC) issues. It should be
noted that no issues related to “extractables and leechables
testing”, that were associated with the previous initial CRL that
the company received relating to the product, were noted by the
FDA. The company’s plan is to provide the FDA with additional
analysis and information in order to attempt to satisfy the CRL
items. The company will request a Type A meeting or consider other
options to resolve the issues.
Dr. Dennis J. Carlo, President and CEO of Adamis, stated, “This
is a very disappointing setback that was totally unexpected since
we completed the extractables and leechables issues that were
associated with the first CRL. To me, it is very surprising to have
new issues brought up this late in the review process. We believe
the comments and recommendations stated in the CRL can be addressed
and overcome. With all of the factors that are currently
contributing to a growing number of fatal overdoses during the
COVID-19 pandemic, we believe there is a clear need for higher dose
forms of intramuscular naloxone found in ZIMHI. We remain committed
to this product and our mission to provide physicians and patients
access to a higher dose of naloxone. As soon as reasonably
possible, we will resubmit additional information and analysis of
data to the FDA for 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. 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.
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 NDA relating
to ZIMHI; the company’s beliefs concerning the results of any
future studies or clinical trials that the company may conduct
relating to ZIMHI or its other products or product candidates; the
company’s beliefs concerning the timing and outcome of the FDA’s
review of the company’s New Drug Application (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,
and/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,
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.
Contact Adamis:Mark FlatherSenior Director,
Investor Relations& Corporate Communications (858)
412-7951mflather@adamispharma.com
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