Adamis Pharmaceuticals Submits New Drug Application to FDA for Its Naloxone Pre-Filled Syringe
31 Diciembre 2018 - 3:02PM
Adamis Pharmaceuticals Corporation (NASDAQ: ADMP) today announced
the submission of a New Drug Application (NDA) to the U.S. Food and
Drug Administration for its naloxone pre-filled single dose syringe
(PFS) product candidate. This injection is designed for the
treatment of an opioid overdose. Adamis submitted the NDA
pursuant to Section 505(b)(2) of the Food, Drug & Cosmetic Act.
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.
Dr. Dennis J. Carlo, President and CEO of Adamis, stated, “This
NDA submission represents another major milestone for Adamis this
year. With the rapid increase in synthetic opioid related
deaths and the persistence of widespread opioid addiction, we
believe that there is a need for additional treatment options to
help combat this crisis. As the awareness builds for this
growing epidemic, we are hoping to provide an affordable solution
to patients at risk. We are excited to be entering 2019 with
the anticipated upcoming launch of Symjepi and having two NDAs
under FDA review. We are continuing to assess additional
compounds for possible use with our injection platform and believe
that we are well positioned for solid growth in 2019.”
About Adamis Pharmaceuticals
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
(epinephrine) Injection 0.3mg and 0.15mg products are FDA approved
for use in the emergency treatment of acute allergic reactions,
including anaphylaxis. Adamis is developing a sublingual
tadalafil product candidate, a naloxone injection product candidate
utilizing its approved injection device, and a metered dose inhaler
and dry powder inhaler devices for the treatment of asthma.
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
matters: the timing or outcome of the FDA’s review of the company’s
NDA relating to its naloxone product candidate; the company’s
beliefs concerning its ability to commercialize the naloxone
product candidate if approved and commercialized; the company’s
beliefs concerning the size of the markets in which the product
candidate will compete if approved; the company’s beliefs
concerning the safety and effectiveness of its products and product
candidates; and other statements concerning our future operations
and activities. 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. The timing
and outcome of the FDA’s review of our NDA is uncertain.
There is no assurance that the FDA will approve the NDA relating to
our naloxone product candidate (or any other NDA that we file) or
that other matters or events relating to the submission and
regulatory review process under Section 505(b)(2) of the Food, Drug
& Cosmetic Act will not differ from our expectations or result
in delays in the regulatory approval 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. 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
our filings from time to time with the SEC, including our annual
report on Form 10-K for the year ended December 31, 2017, 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 CommunicationsAdamis
Pharmaceuticals Corporation (858)
412-7951mflather@adamispharma.com
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