Press Releases

Adamis Pharmaceuticals Announces FDA Acceptance for Review of the New Drug Application of Its Higher Dose Naloxone Injection Product Candidate

SAN DIEGO – 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

Mark Flather
Senior Director, Investor Relations
& Corporate
Adamis Pharmaceuticals Corporation

Adamis Pharmaceuticals logo

ADAMIS Announces Merger With DMK Pharmaceuticals

What is DMK?
Private, clinical-stage, neuro-biotech company
  • Focused on developing potential blockbuster products for underserved patients.
  • Product candidates selected and developed from proprietary library of approximately 750 small molecule neuropeptide analogues with broad utility.

Developing multiple first-in-class products targeting large unmet needs
  • Addiction
  • Acute and chronic pain
  • Parkinson’s disease
  • Bladder control
  • Other neuro-based diseases

Want to learn more?

Read our press release go to our Investor Relations page or visit

Check this page for the most recent updates regarding the merger process.