Adamis Pharmaceuticals Announces FDA Acceptance for Review of the New Drug Application of Its Higher Dose Naloxone Injection ...
14 Marzo 2019 - 2:55PM
Business Wire
Adamis Pharmaceuticals Corporation (NASDAQ: ADMP) today
announced that the U.S. Food and Drug
Administration (“FDA”) has accepted for review the company’s
New Drug Application (“NDA”) for its higher naloxone
injection product candidate for the treatment of opioid
overdose. On March 14, 2019, 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 further provided a target agency action date of
October 31, 2019.
About Naloxone
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 (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 the
proliferation of more powerful synthetic opioids, like fentanyl and
its analogues, could result in future increases in the number of
deaths resulting from opioid overdoses. The current epidemic of
drug overdoses is killing people at a faster rate than the HIV
epidemic at its peak.
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 has also recommended
co-prescribing naloxone with opioids under certain conditions.
These recommendations could significantly increase the naloxone
market.
About Adamis
Adamis 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 TM
(epinephrine) Injection 0.3mg and SYMJEPI (epinephrine) Injection
0.15mg products were approved by the FDA for use in the emergency
treatment of acute allergic reactions, including anaphylaxis.
Adamis previously announced a distribution and commercialization
agreement with Sandoz, a division of Novartis Group, to market
SYMJEPI in the U.S. Adamis is developing additional products,
including a sublingual tadalafil product candidate for the
treatment of erectile dysfunction, a naloxone injection product
candidate for the treatment of opioid overdose, and 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 use by 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. 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; deaths due to
fentanyl and other opioids; use of naloxone to help treat opioid
overdoses; the use of repeat doses of naloxone to treat fentanyl
and other opioid overdoses; 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 the company’s
ability to successfully develop its naloxone product candidate and
other product candidates. 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,
concerning the timing of any such approval, or that the product
will be commercially successful if approved and introduced.
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.
View source
version on businesswire.com: https://www.businesswire.com/news/home/20190314005895/en/
Mark FlatherSenior Director, Investor Relations& Corporate
CommunicationsAdamis Pharmaceuticals Corporation(858)
412-7951mflather@adamispharma.com
Adamis Pharmaceuticals (NASDAQ:ADMP)
Gráfica de Acción Histórica
De Jun 2024 a Jul 2024
Adamis Pharmaceuticals (NASDAQ:ADMP)
Gráfica de Acción Histórica
De Jul 2023 a Jul 2024