Opiant Pharmaceuticals Announces Additional $3.5 million Funding Under BARDA Contract for OPNT003 Nasal Nalmefene Development...
14 Dezember 2020 - 10:01PM
Opiant Pharmaceuticals, Inc. (“Opiant”) (NASDAQ: OPNT) today
announced an additional commitment of up to $3.5
million from the Biomedical Advanced Research and Development
Authority (“BARDA”), part of the Office of the Assistant Secretary
for Preparedness and Response at the U.S. Department of Health and
Human Services, to advance the clinical development of OPNT003,
nasal nalmefene, for opioid overdose. The contract modification
increases the total potential value of the BARDA contract to $8.1
million.
“We thank BARDA for their ongoing support of OPNT003, nasal
nalmefene,” said Roger Crystal, M.D., President and Chief
Executive Officer of Opiant. “We believe OPNT003, nasal nalmefene,
has the potential to be a best-in-class rescue agent for preventing
opioid overdose deaths, particularly from synthetic opioids like
fentanyl. We remain on track to file a New Drug Application with
the U.S. Food and Drug Administration by the end of 2021.”
An earlier award from BARDA for up to $4.6 million,
combined with a $7.4 million grant Opiant received from
the National Institute on Drug Abuse (“NIDA”), also
supports the clinical development and U.S. regulatory submission of
OPNT003. The additional BARDA support will fund both a planned
pharmacodynamic study in healthy volunteers and development work
associated with the use of Aptar Pharma’s Unit Dose System.
Opioid overdose is a significant public health crisis that has
been exacerbated by the increased availability and abuse of
synthetic opioids, such as fentanyl. Fentanyl is 50-fold more
potent than heroin, far easier and less expensive to produce, and
has a significantly longer half-life. Fentanyl and related
synthetic opioids were linked to more than 75% of the nearly 51,000
opioid overdose deaths in 2019 in the U.S. The contract with BARDA
allows for development of OPNT003 as a medical countermeasure in a
chemical attack using synthetic opioids.
This project has been supported in part with federal funds from
the Department of Health and Human Services; Office of the
Assistant Secretary for Preparedness and Response; Biomedical
Advanced Research and Development Authority, under Contract No.
HHSO100201800029C.
About OPNT003 OPNT003, nasal nalmefene, is in
development as a potent, rapid-onset, long-acting opioid antagonist
for the treatment of opioid overdose. OPNT003 is designed as a
rescue medication that could be especially useful in treating
overdose by high-potency synthetic opioids, such as fentanyl.
OPNT003 is also being considered as an antidote in a civilian mass
casualty event. The development of OPNT003 is supported by grants
from the NIH and BARDA. Opiant intends to pursue a 505(b)(2)
regulatory pathway 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,
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and among other things, our ability to maintain cash balances and
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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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