Adamis Pharmaceuticals Receives a Complete Response Letter from the FDA Regarding ZIMHI
November 25 2019 - 8:00AM
Adamis Pharmaceuticals Corporation (NASDAQ: ADMP) (“Adamis”) today
announced that after the close of U.S. markets on November 22nd, 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 Chemistry, Manufacturing and Controls (CMC). The
plan is to expand on the CMC testing that has already been provided
to the FDA to satisfy the CRL items. No other clinical
safety or efficacy issues were raised, and the New Drug Application
will remain open until the CMC issues are resolved.
Dr. Dennis J. Carlo, President and CEO of Adamis,
stated, “Obviously, we are very surprised and disappointed.
With a growing number of fatal overdoses as a result of more
potent opioids like fentanyl, we believe there is an obvious need
for higher dose forms of naloxone and we remain committed to
bringing ZIMHI to the market. We believe the comments and
recommendations stated in the CRL are manageable and plan to fully
cooperate with the FDA. We remain committed to this product
and our mission to provide physicians and patients access to a
higher dose of naloxone. We will take the Agency’s suggestion
and request a meeting as soon as reasonably possible to discuss our
plan to resubmit 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 2017, drug overdoses resulted in
approximately 72,000 deaths in the United States –
greater than 195 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
respiratory disease, allergy and opioid overdose. The
company’s SYMJEPI (epinephrine) Injection 0.3mg and SYMJEPI
(epinephrine) Injection 0.15mg products both use the same injection
device as used for ZIMHI and were approved by the FDA for use in
the emergency treatment of acute allergic reactions, including
anaphylaxis, and both were fully launched in the U.S. in July
2019. Please refer to www.SYMJEPI.com for additional product
information. In addition to its ZIMHI (naloxone) injection
product, Adamis is developing other products, including a metered
dose inhaler and dry powder inhaler product candidates for the
treatment of asthma and COPD. The company’s subsidiary, U.S.
Compounding, Inc., compounds sterile prescription drugs, and
certain nonsterile drugs for patients, animals, hospitals, clinics
and surgery centers 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
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. 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, that the FDA
will approve our NDA relating to our ZIMHI product or concerning
the timing of any future action by the FDA on our NDA, regarding
the commercialization options that the company will pursue if our
NDA is approved, 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 may 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 Flather
Senior Director, Investor Relations& Corporate Communications
(858) 412-7951mflather@adamispharma.com
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