Opiant Pharmaceuticals Announces First Patient Dosed in Confirmatory Pharmacokinetic Study Assessing OPNT003, Nasal Nalmefene...
08 Februar 2021 - 10:01PM
Opiant Pharmaceuticals, Inc. (“Opiant”) (NASDAQ: OPNT) today
announced the dosing of the first patient in a confirmatory
pharmacokinetic (“PK”) study for OPNT003, nasal nalmefene, for the
treatment of opioid overdose. Results from the study are
anticipated June 2021.
Deaths resulting from opioid overdose are at record levels,
driven in large part by high-potency synthetic opioids, such as
fentanyl. In 2017, the National Institutes of Health’s (“NIH”)
leadership called for longer lasting and stronger opioid overdose
reversal agents in response to this escalating public health
crisis¹.
“OPNT003 represents a potentially promising new approach for
treating opioid overdoses,” said Roger Crystal, M.D., CEO and
President, Opiant. “In our initial pilot PK study, OPNT003
demonstrated its potential to work quickly, while offering a longer
duration of action compared to currently available opioid overdose
rescue medicines. The availability of another therapeutic option
that has the potential to act more quickly and last longer could
provide a valuable tool in the fight against opioid overdose at a
time when deaths continue to increase to historic proportions."
The open label, randomized, crossover study will enroll 68
healthy volunteers and determine the pharmacokinetic profile of
intranasally administered nalmefene compared to intramuscularly
administered nalmefene. Opiant also intends to conduct a separate
pharmacodynamic study in healthy volunteers later this year. The
development of OPNT003 is supported by grants from the National
Institute on Drug Abuse (“NIDA”), part of the NIH, and
the Biological Advance Research and Development Agency
(“BARDA”).
The Company plans to file a 505(b)(2) New Drug Application for
OPNT003 with the U.S. Food and Drug Administration by the
end of 2021.
About Synthetic OpioidsSynthetic opioids, such
as fentanyl, are responsible for more overdose deaths than either
heroin or prescription opioids, with over 47,000 fatalities linked
to synthetic opioids during the 12 months ending May 2020.
Synthetic opioids are more potent than heroin (e.g., fentanyl is 50
times more potent than heroin), and especially dangerous because of
a rapid onset of action and long half-life. These properties of
fentanyl and related synthetic opioids may require continuous
monitoring of overdose victims and repeated dosing with
short-acting reversal agents like naloxone to initially resuscitate
a patient and prevent relapse.
About OPNT003OPNT003, nasal nalmefene, is in
development as a potent, rapid-onset, long-acting opioid antagonist
for the treatment of opioid overdose. OPNT003 is designed as a
rescue medication that could be especially useful in treating
overdose by high-potency synthetic opioids, such as fentanyl.
OPNT003 is also being considered as an antidote in a civilian mass
casualty event. The development of OPNT003 is supported by grants
from the NIH and the BARDA. Opiant intends to pursue a
505(b)(2) regulatory pathway for OPNT003.
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 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,
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 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
- Volkow, N., Collins, F. The Role of Science in Addressing
the Opioid Crisis. N Engl J Med. 2017. 377:391-394
For Media and Investor Inquiries:Ben Atkins, Opiant(310)
598-5410batkins@opiant.com
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