Adamis Pharmaceuticals Announces Publication Demonstrating PET Scan Results of Higher Dose Naloxone in Monkeys
April 23 2020 - 9:00AM
Adamis Pharmaceuticals Corporation (NASDAQ: ADMP) (“Adamis”)
announced publication in the peer reviewed journal Molecules, “The
Effects of Intramuscular Naloxone Dose on Mu Receptor Displacement
of Carfentanil in Rhesus Monkeys”
(https://www.mdpi.com/1420-3049/25/6/1360).
Naloxone is an opioid antagonist that binds the opioid receptors
in the brain (mu receptors) and displaces opioid-bound drugs
thereby reversing toxicity and resuscitating an overdose victim.
However, we and others believe that a higher dose of naloxone is
required to resuscitate an opioid overdose caused by more potent
synthetic opioids. In this study, monkeys received doses of
carfentanil, a synthetic opioid 10,000 times stronger than morphine
and 100 times more potent than fentanyl, followed by different
doses of naloxone. The monkeys were then examined using PET
(Positron Emission Tomography) imaging of the brain to observe the
number of brain receptors bound with naloxone. The study found that
higher doses of naloxone resulted in an increased number of
naloxone-bound brain receptors, thereby lowering the number of
brain receptors bound with the opioid. A higher level of naloxone,
similar to levels produced by Adamis’ ZIMHI™ product candidate,
displaced more carfentanil bound to receptors compared to lower
naloxone levels typically observed with current lower dose marketed
naloxone products. The authors concluded that “the results suggest
that higher doses of IM naloxone result in higher receptor
occupancy and could be useful in combating overdoses resulting from
potent synthetic opioids”. The study was conducted by researchers
at the University of Michigan and was funded by Adamis
Pharmaceuticals.
Prior to the COVID19 outbreak, accidental overdoses were already
the leading cause of death among Americans under 50, and there is
now concern that one indirect effect of the pandemic will be an
increase in overdose deaths
(https://abcnews.go.com/US/officials-worry-potential-spike-overdose-deaths-amid-covid/story?id=70149746)
(https://www.politico.com/news/2020/04/10/trump-officials-health-experts-worry-coronavirus-will-set-back-opioid-fight-179257).
Dr. Dennis J. Carlo, President and Chief Executive Officer of
Adamis commented: “We are pleased to see these published study
results support the use of a higher dose naloxone product, such as
the one we are developing. We believe our ZIMHI naloxone injection
could fill a void that currently exists in treating overdoses that
result from more potent synthetic opioids. In the midst of the
present COVID-19 pandemic, the need for a higher dose naloxone
product may be greater than ever before. Adamis remains on track
for re-submitting our New Drug Application for our ZIMHI product
candidate in the second quarter of 2020 and is currently in late
stage partnering discussions.”
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 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 both use the same injection device as
used for ZIMHI and 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 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 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. 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
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