Opiant Pharmaceuticals Announces Additional $2.1 Million Funding Under BARDA Contract for OPNT003, Nasal Nalmefene
August 08 2022 - 4:05PM
Opiant Pharmaceuticals, Inc. (“Opiant”) (NASDAQ: OPNT) today
announced that the Biomedical Advanced Research and
Development Authority (BARDA) has awarded an additional
approximately $2.1 million to support OPNT003, nasal
nalmefene, for the treatment of opioid overdose. The increase in
funding is primarily directed towards the preparation and filing of
a New Drug Application (NDA) for OPNT003 to the U.S. Food and Drug
Administration (FDA).
“We greatly appreciate BARDA’s support for OPNT003,”
said Roger Crystal, M.D., President and Chief Executive
Officer of Opiant. “The worsening opioid overdose crisis, driven
particularly by the ever present threat of illicit synthetic
opioids, such as fentanyl, underscores the need for overdose
reversal treatment options.”
A record number of people in the United States (U.S.), over
80,000, died of an opioid overdose during the 12 months ending
February 2022, according to provisional data from the U.S. Centers
for Disease Control and Prevention (CDC). Eighty-nine percent –
nearly 73,000 – of opioid overdose deaths were linked to synthetic
opioids, driven by fentanyl.1 For each opioid-induced
fatality, there are between 6.4-8.4 non-fatal overdoses which can
lead to long-term physical and mental disability.2
OPNT003, a nasal formulation containing the high affinity opioid
antagonist, nalmefene, was studied in three clinical trials: a
pharmacokinetic (PK) study comparing OPNT003 to an
intramuscular nalmefene injection, a second PK
study comparing a single intranasal dose to a single dose
in each nostril or two doses in a single nostril, and a
pharmacodynamic (PD) study comparing nasal nalmefene to nasal
naloxone in reversing opioid-induced respiratory
depression. The PK studies demonstrated rapid absorption and
higher plasma concentrations versus intramuscular injection.3,4 In
the PD study, OPNT003 met the primary endpoint of non-inferiority
to nasal naloxone, producing a reversal in remifentanil-induced
respiratory depression that was nearly twice that produced by nasal
naloxone at five minutes.5 Opiant has initiated rolling submission
of an NDA to the FDA for OPNT003 using the 505(b)(2) pathway and
intends to complete the filing in the second half of 2022. OPNT003
was granted Fast Track Designation in November 2021.
Earlier awards from BARDA for $8.7 million, combined with
a $7.4 million grant Opiant received from
the National Institute on Drug Abuse, have also supported the
clinical development and U.S. regulatory submission of OPNT003. The
contract with BARDA will also 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 within the U.S. Department of Health
and Human Services. This project has been funded in whole or
in part with federal funds from the Department of Health and Human
Services; Administration for Strategic Preparedness and Response;
Biomedical Advanced Research and Development Authority, under
contract number HHSO100201800029C.
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 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, completion of the NDA filing in the second half of 2022. 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 quarter
ended March 31,2022, filed with the Securities and Exchange
Commission on March 4, 2022 and May 10, 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
1. Ahmad FB, Rossen LM, Sutton P. Provisional drug
overdose death counts. National Center for Health Statistics.
2022.2. Skolnick P. Treatment of overdose in the synthetic
opioid era. Pharmacology & Therapeutics. 2022.3.
ClinicalTrials.gov Identifier: NCT047597684.
ClinicalTrials.gov Identifier: NCT052196695.
ClinicalTrials.gov Identifier: NCT04828005
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