USWM, LLC (US WorldMeds), and Adamis Pharmaceuticals Corporation
(NASDAQ: ADMP), today announced the U.S. launch and availability of
ZIMHI™ (naloxone HCL Injection, USP) 5 mg/0.5 mL. ZIMHI is a
high-dose naloxone injection product FDA-approved for use in the
treatment of opioid overdose as emergency therapy in settings where
opioids may be present.
According to the Centers for Disease Control and Prevention
(CDC), drug overdoses are now the leading cause of death for
Americans under age 50, with more powerful synthetic opioids, like
fentanyl and its analogs, responsible for the largest number of
those deaths. Approximately 85% of all opioid overdose related
deaths are now caused by fentanyl, fentanyl analogs, and other
synthetic opioids. Drug overdoses resulted in over 100,000 deaths
in the United States during the 12-month period ending April 2021,
which was a 29% increase over the prior 12-month period.
“ZIMHI represents an important new tool for caregivers and
patients by combining an intuitive, compact, and simple to use
intramuscular device with a high dose of naloxone. Successfully
treating overdoses involving fentanyl often requires multiple doses
of lower-dose or intranasal naloxone products, creating an urgent
need for new tools to help combat these more powerful opioids,”
said P. Breckinridge Jones, Sr., CEO of US WorldMeds.
Dr. Dennis J. Carlo, President and CEO of Adamis, stated, “ZIMHI
provides the highest intramuscular dose of naloxone among naloxone
injection devices currently available. We are very excited to once
again partner with US WorldMeds to launch ZIMHI. We believe that
ZIMHI will play a pivotal role in the treatment of opioid overdose,
while contributing positively to the entire community that has been
impacted by the opioid epidemic.”
ZIMHI is available with discounted public interest pricing for
first responders and other community health organizations, with
additional information available via email to
ZIMHIPublicHealthInfo@usworldmeds.com or at
zimhi.com/public-service/.
Patient accessibility is further enhanced with a co-pay program
that provides ZIMHI to eligible patients for as little
as $0. Most pharmacies across the country are covered
through the program with savings being automatically applied.
Physicians, pharmacists or other healthcare providers with
questions about ZIMHI should visit www.zimhi.com.
IndicationsZIMHI is an opioid antagonist
indicated in adult and pediatric patients for the emergency
treatment of known or suspected opioid overdose, as manifested by
respiratory and/or central nervous system depression. ZIMHI is
intended for immediate administration as emergency therapy in
settings where opioids may be present. ZIMHI is not a substitute
for emergency medical care.
Important Safety Information for Patients
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.
About Naloxone
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.
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.
About US WorldMeds
US WorldMeds is a privately held specialty pharmaceutical
company that develops, licenses, and markets unique healthcare
products designed to improve the lives of patients with challenging
conditions and unmet medical needs. US WorldMeds has built a
branded product portfolio in the therapeutic areas of opioid use
disorder medicine, hemophilia, and malignant hyperthermia. More
information on US WorldMeds can be found at
www.usworldmeds.com.
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 Adamis and
follow us on Twitter and LinkedIn.
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
marketplace acceptance and commercial success of ZIMHI, the medical
and commercial need for additional products and tools to help
combat more powerful opioids, the effectiveness and success of
ZIMHI in the treatment of opioid overdose, and other statements
concerning Adamis’ future operations and activities. 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. Adamis 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, Adamis undertakes 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 most recent annual
report on Form 10-K 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 web site at
http://www.sec.gov.
Contact:
Adamis Investor RelationsRobert UhlManaging DirectorICR
Westwicke 619.228.5886robert.uhl@westwicke.com
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