Opiant Pharmaceuticals Partners with Aptar Pharma for Nasal Nalmefene Opioid Overdose Treatment
29 Oktober 2020 - 9:05PM
Opiant Pharmaceuticals, Inc. (“Opiant”) (NASDAQ: OPNT) today
announced it has entered into an agreement with drug delivery
specialist Aptar Pharma (“Aptar”), for the development of OPNT003
nasal nalmefene for use in conjunction with Aptar’s Unit Dose
System (UDS) for the treatment of opioid overdose.
The Aptar UDS has been approved by the U.S. Food and Drug
Administration (FDA) with multiple drug products marketed
in the United States, including our internally developed and
licensed NARCAN® Nasal Spray.
“We believe our decision to partner with Aptar’s proven nasal
delivery system represents a timely and strategic step forward for
Opiant as we continue to advance OPNT003 as a potentially
life-saving treatment for opioid overdose in the face of America’s
worsening opioid epidemic,” said Roger Crystal, MD, President and
Chief Executive Officer of Opiant.
Opioids were involved in 51,574 overdose deaths in 2019 (71% of
all drug overdose deaths) according to provisional data by the
Centers for Disease Control and Prevention (CDC). Three out of four
opioid-involved overdose deaths involve synthetic opioids, such as
fentanyl, which is 50 times more potent than heroin. The COVID-19
coronavirus has worsened the outlook for 2020. The American Medical
Association (AMA) recently cited that more than 40 states have
reported rising opioid overdose-related fatalities amid the
pandemic.
OPNT003, nasal nalmefene, is being investigated to
treat opioid overdose, which, if proven and ultimately
approved, may be particularly useful in treating overdoses stemming
from use of synthetic opioids, such as fentanyl. The development of
OPNT003 is supported by a grant from the National Institutes of
Health (NIH) and a contract from the Biological Advance
Research and Development Agency (BARDA), who are interested in
its potential as an antidote for use in a civilian mass casualty
event. Opiant continues to anticipate filing a New Drug Application
(NDA) in the United States for OPNT003 under a 505(b)(2) filing
strategy by the end of 2021.
In parallel, Opiant terminated an agreement with Aesica
Queenborough Limited (which was ultimately acquired by Recipharm
upon its acquisition of Consort Medical plc, and its Bespak
Division, in 2019) to use its Unidose® Xtra device for
OPNT003.
About Opiant Pharmaceuticals,
Inc. Opiant Pharmaceuticals, Inc., the company that
developed NARCAN® Nasal Spray, is building a
leading franchise of new medicines to combat addictions
and drug overdose.For more information
visit: www.opiant.com.
Forward-Looking StatementsThis press release
contains forward-looking statements. These statements relate to
future events or our future financial performance and involve known
and unknown risks, uncertainties and other factors that may cause
our or our industry's actual results, levels of activity,
performance or achievements to be materially different from any
future results, levels of activity, performance or achievements
expressed, implied or inferred by these forward-looking statements,
and among other things, our ability to maintain cash balances and
successfully commercialize or partner our product candidates
currently under development. In some cases, you can identify
forward-looking statements by terminology such as "may," "will,"
"should," "could," "would," "expects," "plans," "intends,"
"anticipates," "believes," "estimates," "predicts," "projects,"
"potential," or "continue" or the negative of such terms and other
comparable terminology. These statements are only predictions based
on our current expectations and projections about future events.
You should not place undue reliance on these statements. Actual
events or results may differ materially. In evaluating these
statements, you should specifically consider various factors.
Additional factors that could materially affect actual results can
be found in our Form 10-K for the year ended December 31,
2019, filed with the Securities and Exchange
Commission on March 4, 2020, including under the caption
titled "Risk Factors." These and other factors may cause our
actual results to differ materially from any forward-looking
statement. We undertake no obligation to update any of the
forward-looking statements after the date of this press release to
conform those statements to reflect the occurrence of unanticipated
events, except as required by applicable law.
For Media and Investor Inquiries:Ben Atkins, Opiant(310)
598-5410batkins@opiant.com
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