Opiant Pharmaceuticals Announces FDA Acceptance and Priority Review of NDA for OPNT003, Nasal Nalmefene, for Opioid Overdose
January 19 2023 - 4:05PM
Opiant Pharmaceuticals, Inc. (“Opiant”) (NASDAQ: OPNT) today
announced that the U.S. Food and Drug Administration (FDA) has
accepted for review the New Drug Application (NDA) for OPNT003,
nasal nalmefene, Opiant’s product candidate for the treatment of
opioid overdose.
The NDA was granted a Priority Review designation and has been
given a Prescription Drug User Fee Act (PDUFA) action date
of May 22, 2023, accelerating the review time from ten months
to six months from the date of filing. Priority Review is
granted to therapies that the FDA determines have the
potential to provide a significant improvement in the safety or
effectiveness of the treatment, diagnosis or prevention of a
serious condition.
“We are delighted to announce that the FDA has accepted Opiant’s
NDA for OPNT003 for filing and designated it priority review
status,” said Roger Crystal, M.D., President and CEO of Opiant.
“The acceptance of the OPNT003 NDA filing is an important milestone
as it brings us one step closer to the potential approval and U.S.
commercial launch of OPNT003. We believe the data supporting this
NDA indicates that OPNT003 can potentially offer first responders
and communities an important treatment option in tackling the very
serious opioid overdose crisis. We look forward to working with the
FDA during the review process.”
Over 81,000 people in the United States died of an
opioid overdose during the 12 months ended August 31, 2022,
according to provisional data from the U.S. Centers
for Disease Control and Prevention. About 90% – 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.
About OPNT003OPNT003 is a nasal formulation
containing the high affinity opioid antagonist nalmefene. The
505(b)2 NDA submission for OPNT003 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).
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 a 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. 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 15, 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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