Opiant Pharmaceuticals Announces Completion of Rolling NDA Submission for OPNT003, Nasal Nalmefene, for Opioid Overdose
November 22 2022 - 4:01PM
Opiant Pharmaceuticals, Inc. (“Opiant”) (NASDAQ: OPNT) today
announced it has completed submission of its rolling New Drug
Application (NDA) to the U.S. Food and Drug Administration (FDA)
seeking approval for OPNT003, nasal nalmefene, for the treatment of
opioid overdose.
“We are very pleased to submit our NDA for OPNT003,”
said Roger Crystal, M.D., President and Chief Executive
Officer of Opiant. “We believe the data supporting this NDA
indicate OPNT003 can potentially offer first responders and
communities an important treatment option in tackling the very
serious opioid overdose crisis in the United States.”
The NDA submission is supported by results from a
pharmacokinetic (PK) study comparing OPNT003 to an intramuscular
nalmefene injection (NCT04759768), a second PK study comparing a
single intranasal dose to a single dose in each nostril or two
doses in a single nostril (NCT05219669), and a pharmacodynamic
study comparing nasal nalmefene to NARCAN® (naloxone HCI) Nasal
Spray 4mg in a clinical model of opioid induced respiratory
depression (NCT04828005).
The FDA decision on NDA filing acceptance is expected in
February 2023.
Over 81,000 people in the United States died of an opioid
overdose during the 12 months ended May 31, 2022, according to
provisional data from the U.S. Centers for Disease Control and
Prevention. About 90% percent – approximately 73,000 – of opioid
overdose deaths were linked to potent synthetic opioids, driven by
illicit fentanyl. For each opioid-induced fatality, it has
been estimated there are 6.4-8.4 non-fatal overdoses that can lead
to long-term physical and mental disability.
An award from the Biomedical Advanced Research and Development
Authority (BARDA) for up to $10.8 million, combined with
a $7.4 million grant Opiant received from
the National Institute on Drug Abuse, have supported the
clinical development and U.S. regulatory submission of OPNT003. The
contract with BARDA will potentially allow for the development of
OPNT003 as a medical countermeasure in a chemical attack using
weaponized synthetic opioids as well as reversal of opioid
overdoses in the community.
BARDA is part of the Administration for Strategic
Preparedness and Response (ASPR) within the U.S. Department of
Health and Human Services (HHS). This project has been funded
in whole or in part with federal funds from HHS/ASPR/BARDA, under
contract number HHSO100201800029C.
About Opiant Pharmaceuticals,
Inc. Opiant Pharmaceuticals, Inc., 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 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, expectation of the FDA’s written decision on filing
acceptance of the NDA in February 2023. 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, 2021
and our Form 10-Q for the quarters ended March 31, 2022, June 30,
2022, and September 30, 2022, filed with the Securities and
Exchange Commission on March 4, 2022, May 10, 2022,
August 11, 2022, and November 14, 2022, respectively, 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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