Adamis Provides Update on ZIMHI™
June 09 2021 - 7:30AM
Adamis Pharmaceuticals Corporation (NASDAQ: ADMP) today
announced that the U.S. Food and Drug Administration (FDA) has
accepted for review the Company’s resubmitted New Drug Application
(NDA) for ZIMHI™, which is its higher naloxone injection product
candidate for the treatment of opioid overdose. Adamis received FDA
correspondence relating to the Company’s NDA, stating that the
Agency had completed its filing review and had determined that the
NDA was sufficiently complete to permit a substantive review. The
FDA also provided a target action date under the Prescription Drug
User Fee Act (PDUFA date) of November 12, 2021.
“We are pleased with the FDA’s decision to accept for review our
NDA for ZIMHI. I believe this underscores the need for additional
treatment alternatives for narcotic overdose,” said Dr. Dennis J.
Carlo, President and Chief Executive Officer of Adamis
Pharmaceuticals. “We look forward to working collaboratively with
the FDA during the review process to support the case for approval
of ZIMHI.”
About Naloxone and the Growing Crisis of Opioid
Overdose
- Naloxone is an opioid antagonist used to treat narcotic
overdoses and is generally considered the treatment of choice for
immediate administration in instances of opioid overdose.
- Naloxone blocks or reverses effects of the opioid, including
extreme drowsiness, slowed breathing and loss of
consciousness.
- Common opioids include morphine, heroin, tramadol, oxycodone,
hydrocodone and fentanyl.
- The number of deaths due to opioids has increased over 5X since
1999. According to statistics published by the Centers for Disease
Control and Prevention.
- In the 12 months ending May 2020, drug overdoses resulted in
approximately 81,000 deaths in the United States – greater than
approximately 220 deaths per day.
- Drug overdoses are now the leading cause of death for Americans
under 50.
- The proliferation of more powerful synthetic opioids, such as
fentanyl and its analogues, could result in future increases in the
number of deaths resulting from opioid overdoses.
Recent studies from 2013 to 2016 have revealed an approximately
87% increase in deaths associated with synthetic opioids, whereas
death rates due to natural and semisynthetic opioids remained
relatively stable. In response to this significant increase in
synthetic opioid abuse, there have been published studies that
suggest the current recommended doses of naloxone may be inadequate
and frequent redosing is likely required. Repeat dosing of the
commonly utilized dose of naloxone suggests the need for a higher
dosage product.
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. Adamis’ naloxone injection
product candidate, ZIMHI, for the treatment of opioid overdose is
currently under FDA review. Adamis is developing additional
products, including treatments for acute respiratory diseases, such
as COVID-19, influenza, asthma, and COPD. The company’s subsidiary,
US Compounding Inc. (USC), compounds sterile prescription
drugs, and certain nonsterile drugs for human and veterinary use by
hospitals, clinics, surgery centers, and vet clinics throughout
most of the United States. For additional information about Adamis
Pharmaceuticals, please visit www.adamispharmaceuticals.com.
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 regarding the timing or outcome
of our resubmission of the NDA to the FDA or the FDA’s review of
the resubmitted NDA relating to the ZIMHI product, whether the FDA
will regard the resubmitted NDA as satisfactory, whether the FDA
will require additional actions, information or trials after review
of a resubmitted NDA or issue another CRL, or the timing, costs or
outcome of any additional actions that may be required following
any resubmission of the NDA, or that the product will be able to
compete successfully in the market if approved and launched. the
Company’s beliefs concerning the safety and effectiveness of ZIMHI
or the Company’s other product candidates; the Company’s ability to
commercialize the product candidates described in this press
release, itself or through commercialization partners; 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 ability
to enforce its patents and other intellectual property rights
against third parties; and other statements concerning our 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. 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 web site at http://www.sec.gov.
Contact:
Adamis Investor RelationsRobert UhlManaging DirectorWestwicke
ICR619.228.5886robert.uhl@westwicke.com
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