Opiant Pharmaceuticals Announces Additional $2.2 million Funding Under BARDA Contract for OPNT003 Nasal Nalmefene Development Program
24 Januar 2022 - 10:05PM
Opiant Pharmaceuticals, Inc. (“Opiant”) (NASDAQ: OPNT) today
announced a modification to its contract with the Biomedical
Advanced Research and Development Authority (“BARDA”) for an
additional commitment of up to $2.2 million to support
OPNT003, nasal nalmefene, for opioid overdose. The increase in
funding is primarily directed toward the costs of Opiant’s clinical
studies to support its submission of OPNT003 to the Food and Drug
Administration (“FDA”).
Opiant is currently completing a non-inferiority
pharmacodynamic (“PD”) study comparing nasal nalmefene with nasal
naloxone in reversing respiratory depression produced by
remifentanil, a synthetic opioid. In a confirmatory pharmacokinetic
(“PK”) study, conducted last year, OPNT003 exhibited fast
absorption and high plasma concentrations that surpassed
intramuscular nalmefene, as well as a comparable long duration.
These are attributes that support OPNT003 as a potential major
advance in opioid overdose reversal. OPNT003 is being developed
using a 505(b)(2) pathway, with PK and PD studies supporting NDA
submission. In November 2021, the FDA granted OPNT003 Fast Track
Designation.
“A national crisis of opioid overdose requires
innovation to save lives, and we believe OPNT003, nasal nalmefene,
has the potential to offer an important new overdose treatment in
the community,” said Roger Crystal, M.D., President and Chief
Executive Officer of Opiant. “BARDA has been an outstanding partner
for OPNT003, and we are excited to advance closer to New Drug
Application (“NDA”) submission this year with their support.”
Opioid overdose is a significant public health
crisis that has been exacerbated by the increased availability and
abuse of synthetic opioids, such as fentanyl. In a 12-month period
that ended in June 2021, over 76,000 people in the U.S. died from
an opioid overdose1.
Earlier awards from BARDA for up to $8.1
million, combined with a $7.4 million grant Opiant
received from the National Institute on Drug Abuse, also
support 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
reverse opioid overdoses in the community.
BARDA is part of the Office of the
Assistant Secretary for 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; Office of the
Assistant Secretary for Preparedness and Response; Biomedical
Advanced Research and Development Authority, under Contract No.
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.
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relate to future events or our future financial performance and
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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
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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.
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