Adamis Pharmaceuticals Provides Regulatory Update for Its Higher Dose Naloxone Pre-Filled Syringe
05 November 2019 - 2:00AM
Adamis Pharmaceuticals Corporation (NASDAQ: ADMP) (“Adamis”) today
announced that as of the close of business today, Adamis has not
received any notice of action from the U.S. Food and Drug
Administration (“FDA”) on the company’s New Drug Application
relating to its ZIMHI™ high-dose naloxone injection product for the
treatment of opioid overdose. As Adamis has previously
stated, in connection with its acceptance for review of the NDA the
FDA previously provided a PDUFA target agency action date of
October 31, 2019. However, the FDA’s review processes can
extend beyond, and in some cases significantly beyond, anticipated
or target completion or action dates due to the timing of the FDA’s
review process, FDA requests for additional data, information,
materials or clarification, difficulties scheduling an advisory
committee meeting, FDA workload issues, extensions resulting from
the submission of additional information or clarification regarding
information already in the submission, or other reasons.
Adamis intends to make an announcement relating to FDA action
concerning the NDA after it receives a notice of action or similar
communication from the agency.
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 PharmaceuticalsAdamis
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 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 StatementsThis 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 the timing and outcome
of the FDA’s review of the company’s New Drug Application (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. There can be
no assurances 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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