Adamis Pharmaceuticals Announces Publication of Pharmacokinetic model suggesting that higher doses of naloxone are needed for...
June 18 2020 - 9:00AM
Adamis Pharmaceuticals Corporation (NASDAQ: ADMP) (“Adamis”)
announced today the publication of an article entitled “Higher
naloxone dosing in a quantitative systems pharmacology model that
predicts naloxone-fentanyl competition at the opioid mu receptor
level” in the peer reviewed publication “PLOS ONE, ” This study was
done in collaboration with Rosa and Co.
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. Rapid
resuscitation of an opioid overdose with naloxone, an opioid
antagonist, is critical as opioid induced toxicity results in rapid
death, i.e., delaying adequate resuscitation can result in
death. Accordingly, the current approved naloxone doses (2 mg
intramuscular (IM) and 4 mg intranasal (IN)), since they both give
similar systemic exposure levels, might very well not be sufficient
to reverse high doses of fentanyl. Fentanyl, a synthetic opioid, is
considered 50 to 100 times more potent than morphine. According to
the CDC, powerful synthetic opioids, like fentanyl and its
analogues, are responsible for the largest number of deaths from
opioid overdoses. To this end, it was recently reported that
drug overdoses in British Columbia last month killed more people
there than COVID-19 has all year. The vast majority of the
overdose deaths involved fentanyl. There is no reason to
believe that this same trend is not happening in the U.S.
The manuscript describes an opioid receptor quantitative systems
pharmacology (QSP) model which was developed to predict the effects
of different IM doses of naloxone ( 2 mg, 5 mg, and 10 mg) in
response to different levels of fentanyl exposure (low, medium, and
high). The model defined a successful reversal as lowering the
amount of opioid bound to the brain receptors to less than 50%
within 10 minutes. For the lowest and middle levels of fentanyl
exposure, the model predicted that the 2 mg IM naloxone resulted in
successful resuscitations within ten minutes, but more rapid
reversal was observed with the 5 and 10 mg doses. However, at the
highest level of naloxone exposure, the model predicted that the 2
mg IM (and 4 mg IN) doses of naloxone did not result in a
successful reversal. In contrast, the 5 and 10 mg doses of naloxone
successfully reversed opioid toxicity.
Dr. Dennis J. Carlo, President and CEO of Adamis, stated, “These
results suggest that the current marketed doses of naloxone (2 mg
IM or 4 mg IN) may be inadequate for rapid reversal of toxicity due
to fentanyl exposure and that increasing the dose of naloxone is
likely to improve outcomes. Therefore, it is reasonable to conclude
that our high dose (5 mg IM) naloxone product candidate (ZIMHI) has
the potential to improve outcomes and save lives.”
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 WOLRD MEDS 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 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
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