Opiant Pharmaceuticals Announces Positive Topline Results from Head-to-Head Pharmacodynamic Study Comparing OPNT003, Nasal Nalmefene, to Nasal Naloxone
April 27 2022 - 4:01PM
Opiant Pharmaceuticals, Inc. (“Opiant”) (NASDAQ: OPNT) today
announced positive topline results from a pharmacodynamic (“PD”)
study for OPNT003, nasal nalmefene, (3mg nalmefene hydrochloride),
an investigational treatment for opioid overdose.
This crossover study conducted in healthy volunteers compared 3
mg nasal nalmefene hydrochloride with 4 mg nasal naloxone
hydrochloride in reversing respiratory depression produced by
remifentanil, a synthetic opioid. The two study drugs were assessed
by measuring changes in minute ventilation following administration
of the respective study drug, with the primary endpoint at five
minutes post administration.
A preliminary analysis on the 50 subjects completing the study
found that treatment with OPNT003, nasal nalmefene, produced a
greater reversal of respiratory depression that was nearly twice
that produced by nasal naloxone at five minutes. The increases in
minute ventilation were 5.745 L/min and 3.011 L/min, with nalmefene
and naloxone, respectively. OPNT003 met the primary endpoint of
non-inferiority, which was designed to assess whether nasal
nalmefene performed as well or better than nasal naloxone.
“The findings from this PD study are compelling and add to a
body of non-clinical and clinical evidence demonstrating the
potential of OPNT003, nasal nalmefene, to offer an important
treatment option for opioid overdose,” said Richard C. Dart, M.D.,
Ph.D., Director of the Rocky Mountain Poison & Drug Center,
Denver Health and Hospital Authority, and a member of Opiant’s
Scientific Advisory Board. “Synthetic opioids, such as
fentanyl, are responsible for the great majority of overdoses
today, are far more potent, have a more rapid onset, and can have a
long duration of action. They can quickly depress respiration and
can continue to deprive the brain of oxygen even after
administration of naloxone, the only current FDA-approved treatment
for opioid overdose. Unless quickly reversed, this can cause severe
hypoxic injury to the victim’s organs and brain, and potentially
death.”
“We are thrilled to be sharing positive topline data from our
head-to-head PD study comparing OPNT003, nasal nalmefene, with
nasal naloxone,” said Roger Crystal, M.D., President and Chief
Executive Officer of Opiant. “These data, taken together with our
prior PK studies, suggest that OPNT003 could be well suited to
address the challenges in treating today’s opioid overdoses, which
are driven by synthetic opioids, like fentanyl. It is extremely
rewarding to see this program yield clear, consistent, results, and
we look forward to continuing to work towards submitting our New
Drug Application (“NDA”), which we anticipate occurring in the
second half of this year."
Positive results were previously reported in two separate
pharmacokinetic (“PK”) studies. OPNT003-PK-001 evaluated the PK
behavior of nasal nalmefene compared to nalmefene intramuscular
injection. Nasal nalmefene exhibited both rapid absorption (Tmax 15
min) and high plasma concentrations (Cmax 12.2 ng/ml) that
surpassed an approved dose of intramuscular nalmefene, as well as
having a comparable long plasma half-life. OPNT003-PK-002 compared
the effect of a single dose of nasal nalmefene in one nostril, one
dose in each nostril, and two doses in one nostril. OPNT003
demonstrated dose proportional plasma concentrations to a single
dose, whether administered as a single dose in each nostril or as
two doses in a single nostril, and was safe and well tolerated.
Completion of the PD study concludes the planned clinical
development program for OPNT003.
OPNT003, nasal nalmefene, is being developed using a 505(b)(2)
pathway. The U.S. Food and Drug Administration (“FDA”) granted
Opiant Fast Track Designation for OPNT003 in November 2021. The
Company expects to complete an NDA filing in the second half of
2022.
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 number
HHSO100201800029C; and the National Institute on Drug Abuse
(“NIDA”).
Conference Call
Opiant will discuss OPNT003 topline data on its first quarter
2022 financial results and corporate update conference call with
slides, Tuesday, May 10, 2022, at 4:30 p.m. Eastern Time. To listen
to the conference call, please dial 1-877-407-0792 (domestic) or
1-201-689-8263 (international) using conference ID number 13728852.
The call will also be webcast LIVE with slides and can be accessed
via the Investors section of the Company's website at:
www.opiant.com.
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, submit a New Drug Application 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, filed with the Securities and
Exchange Commission on March 4, 2022, 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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