Adamis Pharmaceuticals Announces Publication of Comparative Pharmacokinetics of Community Use Naloxone Formulations
November 18 2019 - 9:00AM
Adamis Pharmaceuticals Corporation (NASDAQ: ADMP) (“Adamis”)
announced today that an article entitled “Comparative
Pharmacokinetic Analysis of Community Use Naloxone Formulations for
Acute Treatment of Opioid Overdose” was accepted for publication in
the peer reviewed Journal of Addiction Research and Adolescent
Behavior (Link to Article).
The article compares the pharmacokinetics of two community
naloxone formulations (2mg intramuscular (IM) and NARCAN® 4mg
intranasal (IN)) to Adamis’ investigational drug ZIMHI (5mg IM) in
healthy subjects. Overall, the systemic levels of naloxone
associated with the 2mg IM and 4mg IN were similar. By comparison,
the naloxone levels associated with ZIMHI are higher with more
rapid absorption. The authors concluded that “These results support
the notion that higher doses of naloxone result in greater
bioavailability, which may be required for reversal due to the more
potent synthetic opioids such as fentanyl.”
Naloxone is an opioid antagonist used to treat narcotic
overdoses. Naloxone works by reversing the detrimental effects
of the opioid, including slowed breathing, brain dysfunction, loss
of consciousness and death. 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. The
current epidemic of drug overdoses is killing people at a faster
rate than the peak of the HIV epidemic. New provisional data from
the CDC suggests a slight drop in overall deaths due to overdoses
in 2018, but the number of deaths due to illicitly manufactured
synthetic opioids, such as fentanyl, continues to rise.
“Rapid and higher levels of naloxone by intramuscular injection
may be required for resuscitation of overdoses due to the more
potent opiates such as fentanyl. Death after opioid exposure can
occur within minutes. In this comparison, ZIMHI resulted in higher
and more rapid levels of naloxone compared to the other marketed
formulations. In addition, a recent large field trial of opioid
overdoses demonstrated that intramuscular injection of naloxone was
superior to intranasal administration on several important clinical
outcomes (Link to Article). We believe that the higher and more
rapid blood levels provided by ZIMHI intramuscular injection could
provide a competitive advantage and could be part of the solution
for this devastating epidemic,” said Dr. Dennis J. Carlo, President
and Chief Executive Officer of Adamis.
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 were approved by the FDA for use in the
emergency treatment of acute allergic reactions, including
anaphylaxis. In July, Sandoz, a division of Novartis Group,
announced it had fully launched both in the U.S. Please refer to
www.SYMJEPI.com for additional product information. Adamis is
developing additional products, including a naloxone injection
product candidate, ZIMHI, for the treatment of opioid overdose, and
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 for
human and veterinary use, and certain nonsterile drugs for use by
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 the timing
and outcome of the FDA’s review of the company’s New Drug
Application (NDA) relating to its ZIMHI™ (naloxone) Injection
product candidate; the data and interpretation of the data from the
company’s studies pertaining to the ZIMHI product candidate; the
company’s ability to commercialize its product and product
candidates, itself or through commercialization partners; the
company’s beliefs concerning the ability of its products and
product candidates to compete successfully in the market; the
company’s beliefs concerning the safety and effectiveness of ZIMHI
and its other products and product candidates; and other statements
concerning our future operations and activities. 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 are only predictions, are not guarantees, involve
known and unknown risks, uncertainties and other factors, and
concern matters that could subsequently differ materially from
those described in this press release, which may cause Adamis'
actual results to be materially different from those contemplated
by these forward-looking statements. There can be no assurances
regarding the timing or the outcome of the FDA’s review process
concerning the company’s NDA relating to ZIMHI. There can be no
assurances that the FDA will agree with our
interpretation of study data, will approve our NDA relating to our
naloxone product candidate or will give final approval to our
proposed brand name for the product, concerning the timing of any
such approval, that the product will be commercially successful if
approved and introduced, or concerning the outcome of any
discussions with third parties concerning commercialization of the
product. 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. We cannot assess the impact of each factor
on our business or the extent to which any factor, or combination
of factors, may cause actual results to differ materially from
those contained in any forward-looking statements. 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, and additional risks,
uncertainties, and other factors are described in greater detail in
Adamis’ filings from time to time with the SEC, including its
annual report on Form 10-K for the year ended December 31, 2018,
and our subsequent filings 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.
Contacts:
Mark FlatherSenior Director, Investor Relations& Corporate
CommunicationsAdamis Pharmaceuticals Corporation(858)
412-7951mflather@adamispharma.com
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