Adamis Pharmaceuticals Announces Conditional Acceptance by FDA of Proprietary Name for Higher Dose Naloxone Product
14 Mayo 2019 - 8:00AM
Adamis Pharmaceuticals Corporation (NASDAQ: ADMP) announced
today conditional acceptance by the U.S. Food and Drug
Administration (FDA) of the proposed brand name for the company’s
high dose naloxone product candidate. The notification to the
company from the FDA noted that after review, the proposed
proprietary name “Zimhi™” was conditionally acceptable.
Naloxone is an opioid antagonist used to treat narcotic
overdoses. Naloxone, which is generally considered the drug
of choice for immediate administration for opioid overdose, blocks
or reverses 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, in 2017, drug overdoses
resulted in approximately 70,000 deaths in the United
States – nearly 200 deaths per day. Drug overdoses are
now the leading cause of death for Americans under 50, and 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. Based on the
current opioid epidemic, particularly involving the more potent
fentanyl narcotics, we and others have published reports supporting
the need for a higher dose naloxone product
(https://substanceabusepolicy.biomedcentral.com/articles/10.1186/s13011-019-0195-4)
such as Zimhi.
In December 2018, the joint meeting of the Anesthetic and
Analgesic Products Advisory Committee and the Drug Safety and Risk
Management Advisory Committee voted in favor of adding labeling
language that recommends co-prescription of naloxone for all or
some patients prescribed opioids. Medicare (HHS) has also
recommended co-prescribing naloxone with opioids under certain
conditions. These recommendations could significantly
increase the naloxone market.
As announced in December 2018, the company filed a New Drug
Application (NDA) relating to its higher dose naloxone injection
product for the treatment of opioid overdose. On March 14,
2019, the company received notice from the FDA that it had
determined the NDA was sufficiently complete to permit a
substantive review, and the agency provided a target agency action
date of October 31, 2019. Final approval of the brand name is
conditional on FDA approval of the company’s NDA. The company
is currently exploring commercialization options for the Naloxone
product and is engaged in discussions with potential
commercialization and marketing partners. About
AdamisAdamis Pharmaceuticals Corporation is a specialty
biopharmaceutical company primarily focused on developing and
commercializing products in various therapeutic areas, including
respiratory disease and allergy. The company’s
SYMJEPI™ (epinephrine) Injection 0.3mg and SYMJEPI
(epinephrine) Injection 0.15mg products are FDA approved for use in
the emergency treatment of acute allergic reactions, including
anaphylaxis. The company’s subsidiary, U.S. Compounding,
Inc., compounds sterile prescription drugs, and certain nonsterile
drugs for human and veterinary use, to patients, physician clinics,
hospitals, surgery centers and other clients 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. These statements relate to future events or future
results of operations, including, but not limited to the following
statements: the company’s beliefs concerning drug overdoses in the
United States, illicit use of opioids in the United States, and
deaths due to fentanyl and other opioids; use of naloxone to help
treat opioid overdoses; the potential for future growth in the
naloxone market; the company’s beliefs concerning the timing and
outcome of the FDA’s review of the company’s NDA relating to its
naloxone product candidate and its review of the proposed brand
name for the product; the company’s ability to successfully develop
its naloxone product candidate and other product candidates; and
the outcome of any discussions with third parties concerning
commercialization of the product. 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 that
the FDA 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.
The FDA review process is subject to a number of
uncertainties. The FDA could request additional or
different submissions or request additional data, information,
materials or clinical trials or studies, all of which could affect
the timing and outcome of the review process. As a result,
there can be no assurances regarding the timing or the outcome of
the FDA’s review process. 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, 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 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 Flather Senior Director,
Investor Relations& Corporate Communications Adamis
Pharmaceuticals Corporation (858)
412-7951mflather@adamispharma.com
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