Adamis Pharmaceuticals Announces Publication of Pharmacokinetic study comparing ZIMHI to current 2 mg intramuscular dose of n...
May 27 2020 - 9:00AM
Adamis Pharmaceuticals Corporation (NASDAQ: ADMP) (“Adamis”)
announced today the publication of an article entitled “An
open-label, randomized, single-dose, two-period, two-treatment
crossover bioavailability study comparing 5 mg/0.5 ml of
intramuscular naloxone hydrochloride to 2 mg/0.4 ml intramuscular
naloxone hydrochloride autoinjector in healthy subjects“ in the
peer reviewed publication “The Journal of Opioid Management.”
The article compares the pharmacokinetics of the current
intramuscular (IM) doses of naloxone (2 mg dose, Evzio, Kaleo Inc)
to Adamis’ investigational drug ZIMHI (5 mg dose) in healthy
subjects. The 5 mg dose of naloxone significantly increased
pharmacokinetic parameters including Cmax (maximum
concentration), AUC (area under the curve), and t1/2 (biological
half-life) compared to the 2 mg IM dose. This equated to ZIMHI
showing over three times the blood levels compared to the 2 mg IM
dose for some parameters. The authors concluded that “These
results are consistent with the study rationale that indicated that
higher doses of intramuscular naloxone hydrochloride would result
in higher Cmax and AUCs. These PK characteristics may be
desirable for reversing opioid toxicity caused by the higher more
potent synthetic opioids.”
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 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.
We and others believe that a higher dose naloxone is needed as a
counter measure to successfully reverse opioids overdoses due to
the more potent synthetic opioids.
“We have recently resubmitted our NDA to the FDA for our higher
dose naloxone product ZIMHI and are hopeful for a rapid review.
Of note, there have been concerns raised about increased
opioid related deaths indirectly due to COVID-19. We will
continue to work with the FDA and our new partner, US WorldMeds, to
commercialize ZIMHI, as we believe it can make a difference in the
public health response to the opioid 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. On May 11th the Company announced a partnership
with US WorldMeds for the commercialization of ZIMHI and SYMJEPI.
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 results of the study referenced in the
press release and the interpretation of the data from the study;
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, 2019,
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
Adamis Pharmaceuticals (NASDAQ:ADMP)
Historical Stock Chart
From Aug 2024 to Sep 2024
Adamis Pharmaceuticals (NASDAQ:ADMP)
Historical Stock Chart
From Sep 2023 to Sep 2024