Adamis Pharmaceuticals Provides an Update on ZIMHI™
April 12 2021 - 7:00AM
Adamis Pharmaceuticals Corporation (NASDAQ: ADMP) today provided an
update on the status of the company’s New Drug Application (NDA)
relating to its ZIMHI™ high-dose naloxone injection product
intended for the treatment of opioid overdose. The company had a
Type A meeting with the U.S. Food and Drug Administration (FDA) to
review comments on the additional information provided by the
company in response to the FDA’s previous Complete Response Letter
(CRL) regarding the NDA, and also to obtain input from the agency
concerning the resubmission of the NDA. Adamis believes the meeting
was productive and plans to resubmit the NDA for ZIMHI to the FDA
within the next 45 days, absent unexpected delays. The FDA did not
provide a detailed timeline for review but did indicate that it
would attempt to work in an expeditious manner, acknowledging that
the country is in an opioid crisis.
Dr. Dennis J. Carlo, President and Chief Executive Officer
of Adamis Pharmaceuticals, stated, “We believe we obtained
critical feedback from the FDA at our Type A meeting on a number of
issues and also received an acknowledgement of the agency’s
intention to commit to a rapid review of the NDA. Currently, 88,000
deaths due to drug overdoses have occurred in a 12-month period
ending in August 2020 and deaths have increased by 27% during the
COVID-19 pandemic compared to the previous year. I believe the
availability of our higher dose naloxone product could potentially
save thousands of lives.”
In November 2020, the company received a CRL from the FDA
regarding the NDA for Adamis’ ZIMHI high-dose naloxone injection
product intended for the treatment of opioid overdose. Before the
Type A meeting, the company provided responses to the issues that
the FDA determined must be corrected before the agency can consider
approving 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. 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. 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
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 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 or formal dispute
resolution process that the company may initiate relating to the
agency’s decisions regarding the NDA; 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 decision
regarding a resubmitted NDA or after review of a resubmitted 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. The FDA could issue an
additional CRL or require additional studies, or other actions,
data or information, following review or any resubmitted NDA. In
addition, forward-looking statements concerning our anticipated
future activities assume that we have 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.
Contacts:Investor Relations Adamis
Pharmaceuticals Corporation IR@adamispharma.com
Robert UhlManaging Director, Westwicke ICR619.228.5886,
robert.uhl@westwicke.com
Adamis Pharmaceuticals (NASDAQ:ADMP)
Historical Stock Chart
From Mar 2024 to Apr 2024
Adamis Pharmaceuticals (NASDAQ:ADMP)
Historical Stock Chart
From Apr 2023 to Apr 2024