Opiant Pharmaceuticals Initiates Rolling Submission of New Drug Application to U.S. Food and Drug Administration for OPNT003, Nasal Nalmefene, for the Treatment of Opioid Overdose
June 01 2022 - 4:05PM
Opiant Pharmaceuticals, Inc. (Opiant) (NASDAQ: OPNT) today
announced the filing of the first module of its New Drug
Application (NDA) for OPNT003, nasal nalmefene, for the treatment
of opioid overdose. The module was submitted pursuant to a rolling
submission, as agreed with the U.S. Food and Drug Administration
(FDA) during a pre-NDA meeting. As communicated previously, the
Company expects to complete the submission of the NDA using the
505(b)(2) pathway in the second half of 2022.
An estimated record 80,816 Americans died of an
opioid overdose in 2021, a 17% increase over 2020 and a 62%
increase from 2019, according to new data from the U.S. Centers for
Disease Control and Prevention (CDC). Deaths involving synthetic
opioids, including fentanyl, increased from 36,359 in 2019 and
56,516 in 2020, to an estimated 71,238 in 2021.1,2
“The opioid epidemic has evolved with the widening
threat from potent synthetic opioids like fentanyl and there is
significant evidence indicating that a new treatment option is
needed,” said Roger Crystal, M.D., President and Chief
Executive Officer of Opiant. “We believe the results from the
pharmacokinetic (PK) and pharmacodynamic (PD) studies, in which
OPNT003 demonstrated fast, strong, and long-lasting action and a
well-tolerated safety profile, support OPNT003 as a potential new
treatment option for opioid overdose. We look forward to working
with the FDA to complete this rolling submission for OPNT003, nasal
nalmefene, and we will provide an update when the NDA is
completed.”
Opiant was granted Fast Track designation for
OPNT003, nasal nalmefene, in November 2021. The rolling review
process allows Opiant to submit completed sections of its NDA for
review by FDA, rather than waiting until every section of the NDA
is completed before the entire application can be reviewed.
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
(BARDA), under contract number HHSO100201800029C; and the National
Institute on Drug Abuse (NIDA).
About OPNT003, nasal
nalmefeneOPNT003, nasal nalmefene, is a high-affinity
mu-opioid receptor antagonist that reduces the binding of opioids
to this receptor, limiting respiratory depression, the primary
cause of overdose injury and death. In a head-to-head
pharmacodynamic study, OPNT003 produced a reversal of
remifentanil-induced respiratory depression that was nearly twice
that produced by NARCAN® Nasal Spray at the primary endpoint
of five minutes. The intrinsic properties of nalmefene, taken
together with results from Opiant pharmacokinetic and
pharmacodynamic studies, are consistent with the potential of
OPNT003 to provide fast, strong, and sustained reversal of opioid
overdose.
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
- Ahmad FB, Rossen LM, Sutton P. Provisional drug overdose death
counts. National Center for Health Statistics. 2022.
- Hedegaard H, Miniño AM, Spencer MR, Warner M. Drug overdose
deaths in the United States, 1999–2020. NCHS Data Brief, no 428.
Hyattsville, MD: National Center for Health Statistics. 2021.
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