Adamis Pharmaceuticals Announces Submission of Investigational New Drug (IND) Application to the FDA for New Product Candidat...
December 04 2017 - 3:05PM
Adamis Pharmaceuticals Corporation (NASDAQ:ADMP) (“Adamis”)
announced that it has submitted an investigational new drug (IND)
application to the U.S. Food and Drug Administration (FDA) to begin
testing the drug compound naloxone in human patients. Adamis
intends to develop a naloxone injection product candidate utilizing
the same patented SymjectTM syringe drug delivery platform used in
Adamis’ approved SymjepiTM product, which is an epinephrine
injection drug/device combination for the emergency treatment of
acute allergic reactions including anaphylaxis.
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 2016, drug overdoses
resulted in approximately 64,000 deaths in the United States –
greater than 175 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, “Since FDA approval of our Symjepi product, we have
considered other drug candidates for use with our Symject syringe
injection platform. We determined to pursue an IND for
naloxone due to the worsening opioid crisis. With the rapid
increase in fentanyl 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. We
are excited to be moving forward with naloxone and will continue to
assess additional compounds for possible use with our injection
platform.”
About Adamis Pharmaceuticals
Adamis Pharmaceuticals Corporation is a specialty
biopharmaceutical company focused on developing and commercializing
products in the therapeutic areas of respiratory disease and
allergy. The company’s first product, Symjepi (epinephrine)
Injection 0.3mg, was approved in June 2017 for use in the emergency
treatment of acute allergic reactions, including anaphylaxis.
In addition to the naloxone injection product candidate, Adamis’
product pipeline includes HFA metered dose inhaler and dry powder
inhaler products for the treatment of bronchospasm and
asthma.
The company’s U.S. Compounding, Inc. (USC) subsidiary, which is
registered as a drug compounding outsourcing facility under Section
503B of the U.S. Food, Drug & Cosmetic Act and the U.S. Drug
Quality and Security Act, compounds sterile prescription drugs, and
certain nonsterile drugs, 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 the timing and outcome
of the FDA’s review of the company’s Investigational New Drug
Application relating to its naloxone product candidate, and the
outcome of any further studies or trials relating to that product
candidate; future developments concerning the opioid crisis in the
United States; the company’s ability to commercialize its products
and product candidates; the company's beliefs concerning the
ability of its products and product candidates to compete
successfully in the market; and the company's beliefs concerning
the safety and effectiveness of its products and product
candidates. 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 those
contemplated by these forward-looking statements. Certain of
these risks, uncertainties, and other factors are described in
greater detail in Adamis’ filings from time to time 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. Any forward-looking statement in
this press release speaks only as of the date on which it is
made. Except to the extent required by law, Adamis expressly
disclaims any obligation to update any forward-looking
statements.
Contacts:Mark Flather Senior Director, Investor
Relations& Corporate Communications Adamis Pharmaceuticals
Corporation (858) 412-7951mflather@adamispharma.com
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