Opiant Receives FDA Fast Track Designation for OPNT003, Nasal Nalmefene, for Treatment of Opioid Overdose
November 04 2021 - 4:05PM
Opiant Pharmaceuticals, Inc. (“Opiant”) (NASDAQ: OPNT), a company
advancing medicines to better treat addictions and drug overdose,
today announced that the U.S. Food and Drug Administration (“FDA”)
has granted fast track designation for OPNT003, nasal nalmefene,
its investigational treatment for opioid overdose.
In July, the Company reported positive results from
a confirmatory pharmacokinetic (“PK”) study comparing OPNT003 to
intramuscular nalmefene injection3. The characteristics OPNT003
exhibited in this study, coupled with nalmefene’s five-fold higher
affinity compared to naloxone4, demonstrate its promise as a
potential new treatment. OPNT003 is currently being studied in an
ongoing pharmacodynamic (“PD”) study comparing it to nasal
naloxone5. Both PK and PD data will form the basis of a New Drug
Application (“NDA”) submission using the 505(b)(2) regulatory
pathway.
“Opioid overdoses in the United States are a public
health crisis with rates at the highest level in history and
particularly powerful synthetic opioids like fentanyl, being the
main driver,” said Dr. Roger Crystal, President and CEO,
Opiant. “The designation of Fast Track status by the FDA
underscores the potential for OPNT003 to represent a major advance
in opioid overdose treatment that can help communities better
respond to this escalating crisis. Opiant is focused on advancing
the OPNT003 development program as rapidly as possible and the
granting of Fast Track designation represents significant
additional support toward this objective.”
Synthetic opioids such as fentanyl are
significantly more potent, have a very rapid onset, and a longer
duration of action compared to heroin and prescription opioids.
Synthetic opioids have created a much more dangerous environment
for individuals that are using drugs, and not just those that use
opioids. Fentanyl and related synthetic opioids have made their way
into many substances sold illegally, including cocaine,
methamphetamine and counterfeit pills, and is responsible for the
deaths of thousands of Americans. Synthetic opioids have been found
present in as many as 80% of overdose deaths1. Proving more
resistant to reversal by standard doses of naloxone6, the public
health threat posed by synthetic opioids prompted leadership at the
National Institutes of Health (NIH) to call for the development of
“…stronger, longer-acting formulations of antagonists7…”
Fast Track is an FDA process designed to facilitate
the development and expedite the review of potential therapies that
seek to treat serious conditions and fill an unmet medical need.
Programs with Fast Track designation may benefit from early and
frequent communication with the FDA, in addition to a potential
rolling submission of the marketing application2. For more
information on Fast Track designation, please visit
the FDA's website, available
at https://www.fda.gov/patients/fast-track-breakthrough-therapy-accelerated-approval-priority-review/fast-track.
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, including
statements for OPNT003’s potential as an opioid overdose reversal
agent. 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 or our
industry's 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, our ability to maintain cash balances and successfully
commercialize or partner our product candidates currently under
development. 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, 2020, filed with the Securities and
Exchange Commission on March 4, 2021, 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.
References:
- F. Ahmad et al. Provisional drug overdose death counts.
National Center for Health Statistics (2021).
https://www.cdc.gov/nchs/nvss/vsrr/drug-overdose-data.htm
- U.S. Food and Drug Administration (FDA). Fast Track. Available
from: https://www.fda.gov/patients/fast-track-breakthrough-therapy-accelerated-approval-priority-review/fast-track.
- Opiant Press Release. Link.
- J. Cassel, et al. Alvimopan binding to the μ opioid
receptor: Comparative binding kinetics of opioid antagonists.
European Journal of Pharmacology, 520 (2005),
pp. 29-36
- ClinicalTrials.gov (NCT04828005) Link.
- R. Moss, et al. Higher doses of naloxone are needed
in the synthetic opioid era. Substance Abuse Treatment, Prevention,
and Policy, 14 (2019), p. 6
- Volkow N & Collins F. The role of science in
addressing the opioid crisis. N. Engl. J. Med 377,
391–394 (2017).
For Media and Investor Inquiries:Ben Atkins,
Opiant(310) 598-5410batkins@opiant.com
Opiant Pharmaceuticals (NASDAQ:OPNT)
Historical Stock Chart
From Aug 2024 to Sep 2024
Opiant Pharmaceuticals (NASDAQ:OPNT)
Historical Stock Chart
From Sep 2023 to Sep 2024