Adamis Pharmaceuticals Corporation (NASDAQ: ADMP) announced today
that additional data in a quantitative systems pharmacology model
supports the dose of naloxone hydrochloride that is included in the
company’s ZIMHI™ (naloxone HCL Injection, USP) 5 mg/0.5 mL product.
The model data supports the dose of naloxone in ZIMHI as being more
likely to produce successful resuscitation of high concentration
fentanyl overdoses. These results support the dose of naloxone in
ZIMHI™ as being appropriate for more likely successful
resuscitation from fentanyl overdoses, thereby saving more lives.
The company recently announced that the U.S. Food and Drug
Administration has approved ZIMHI for use in 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. Fentanyl is approximately 100 times more
potent than morphine.
According to statistics published by the Centers for Disease
Control and Prevention (CDC), drug overdoses resulted in
approximately 100,306 deaths in the United States during the
12-month period ending April 2021, which was a 29% increase over
the prior 12-month period. Drug overdoses are now the leading cause
of death for Americans under age 50, with more powerful synthetic
opioids, like fentanyl and its analogues, responsible for the
largest number of those deaths. The deaths represent a new record
high.
The company previously announced 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 &
Co. LLC (www.rosaandco.com). The new data expands the previous
findings to include additional doses of naloxone, comparing the
dose in ZIMHI to the already approved higher intranasal (IN) dose,
and higher levels of fentanyl exposure.
The previous manuscript described an opioid receptor
quantitative systems pharmacology (QSP) model which was developed
to predict the effects of different intramuscular (IM or the
equivalent IN dose) doses of naloxone in response to different
levels of fentanyl exposure (low, medium, high, and very 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 (equivalent to 4 mg IN) naloxone
resulted in successful resuscitations within ten minutes, but more
rapid reversal was observed with the 5 mg IM dose. However, at high
levels of fentanyl exposure, the model predicted that the 2 mg IM
(4 mg IN) doses of naloxone did not result in a successful
reversal. In contrast, the 5 mg IM doses of naloxone (ZIMHI)
successfully reversed opioid toxicity.
The new experiments examined the 4 mg IM (equivalent to 8 mg IN)
dose in the model. The time to decreasing the amount of opioid
(fentanyl) bound to the brain receptors to less than 50% was found
to be earlier for the 5 mg IM dose (found in ZIMHI) compared to the
4 mg IM dose (8 mg IN) at high level of fentanyl exposure. At the
highest fentanyl concentration tested, the 5 mg IM, but not the 4
mg IM (8 mg IN), decreased fentanyl brain receptor occupancy to
less than 50%. Thus, the 5 mg IM resulted in a successful
resuscitation in this model, but the 4 mg IM (8 IN) did not.
Dr. Dennis J. Carlo, President and CEO of Adamis, stated, “We
believe these additional data support the need for ZIMHI’s higher
IM dose of naloxone in the treatment of opioid overdoses,
particularly those that involve fentanyl. The data generated
predicts that ZIMHI will result in more rapid and higher levels of
naloxone when compared to the other available commercial products,
including the recently approved higher IN dose. This should result
in more successful resuscitations and more lives saved. We believe
that our partners at US WorldMeds, who are leaders in the addiction
treatment area, will leverage their commercial infrastructure to
successfully launch ZIMHI.”
About Adamis Pharmaceuticals
Adamis Pharmaceuticals Corporation is a specialty
biopharmaceutical company primarily focused on developing and
commercializing products in various therapeutic areas, including
allergy, opioid overdose, respiratory and inflammatory disease. The
Company’s SYMJEPI (epinephrine) Injection products are approved by
the FDA for use in the emergency treatment of acute allergic
reactions, including anaphylaxis. The Company’s ZIMHI (naloxone)
Injection product is approved for the treatment of opioid overdose.
Tempol is in development for the treatment of patients with
COVID-19 and a Phase 2/3 clinical trial is underway. For additional
information about Adamis Pharmaceuticals, please visit
www.adamispharmaceuticals.com and follow us on Twitter and
LinkedIn.
About ZIMHI™ (naloxone HCL Injection, USP) 5 mg/0.5
mL
ZIMHI is a prescription medicine used in adults and children for
the treatment of an opioid emergency, such as an overdose or a
possible overdose with signs of breathing problems and severe
sleepiness or not being able to respond. ZIMHI is to be given right
away by a caregiver and does not take the place of emergency
medical care. Get emergency medical help right away after the first
dose of ZIMHI, even if the person wakes up.
IMPORTANT SAFETY INFORMATION
Do not use ZIMHI if you are allergic to naloxone hydrochloride
or any of the ingredients in ZIMHI.
ZIMHI is used to temporarily reverse the effects of opioid
medicines. The medicine in ZIMHI has no effect in people who are
not taking opioid medicines.
Use ZIMHI right away if you or your caregiver think signs or
symptoms of an opioid emergency are present, even if you are not
sure, because an opioid emergency can cause severe injury or
death.
Family members, caregivers, or other people who may have to use
ZIMHI in an opioid emergency should know where ZIMHI is stored and
how to give ZIMHI before an opioid emergency happens.
Get emergency medical help right away after using the first dose
of ZIMHI. Rescue breathing or CPR (cardiopulmonary resuscitation)
may be given while waiting for emergency medical help.
The signs and symptoms of an opioid emergency can return within
several minutes after ZIMHI is given. If this happens, give
additional injections using a new ZIMHI prefilled syringe every 2
to 3 minutes and continue to closely watch the person until
emergency help is received.
ZIMHI may cause serious side effects, including sudden opioid
withdrawal symptoms, which may include: body aches, fever,
sweating, runny nose, sneezing, goose bumps, yawning, weakness,
shivering or trembling, nervousness, restlessness or irritability,
diarrhea, nausea or vomiting, stomach cramping, increased blood
pressure, or increased heart rate.
Other common side effects of ZIMHI include dizziness and
injection site redness. In infants under 4 weeks old who have been
receiving opioids regularly, sudden opioid withdrawal may be
life-threatening if not treated the right way. Signs and symptoms
include: seizures, crying more than usual, and increased
reflexes.
These are not all of the possible side effects of ZIMHI. Call
your doctor for medical advice about side effects. To report
SUSPECTED ADVERSE REACTIONS, contact Adamis Pharmaceuticals
Corporation at 1-858-997-2400 or FDA at 1-800-FDA-1088 or
www.fda.gov/medwatch.
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 and additional data described
in this press release and the Company’s beliefs that ZINHI will
result in more rapid and higher levels of naloxone in the
circulation and should result in more successful resuscitations and
more lives saved; the Company’s ability to successfully
commercialize the products and product candidates described in this
press release, itself or through commercialization partners; future
regulatory actions relating to the ZIMHI product; the Company’s
beliefs concerning the benefits, enforceability, and extent of
intellectual property protection afforded by patents and patent
applications that it owns or has licensed and its rights under
applicable license agreements, and its ability to enforce its
patents and other intellectual property rights against third
parties; the Company’s expectations concerning future growth;
expectations and statements about the Company’s strategies,
objectives, future goals and achievements; and other statements
concerning our future operations, activities and financial results.
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 the results
anticipated by such forward-looking statements. There are no
assurances that use of ZIMHI will result in more rapid and higher
levels of naloxone in the circulation or will result in more
successful resuscitations and more lives saved, compared to other
commercially available products. There can be no assurances that
ZIMHI will be able to compete successfully in the market. 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, 2020, and 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 website at
http://www.sec.gov.
Contact:
Adamis Investor RelationsRobert UhlManaging DirectorWestwicke
ICR619.228.5886robert.uhl@westwicke.com
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