Opiant Pharmaceuticals Announces Positive Top-line Results of Confirmatory Pharmacokinetic (PK) Study for OPNT003, Nasal Nalm...
July 06 2021 - 4:01PM
Opiant Pharmaceuticals, Inc. (“Opiant”) (NASDAQ: OPNT) today
announced positive top-line results from its confirmatory
pharmacokinetic (“PK”) study for OPNT003, nasal nalmefene, for
opioid overdose.
The study was conducted in 68 healthy subjects and compared
OPNT003, nalmefene hydrochloride nasal spray, 3 mg, (“nasal
nalmefene”), with an intramuscular nalmefene hydrochloride
injection, 1 mg, which was the comparator previously agreed upon
with the U.S. Food and Drug Administration (“FDA”). According to an
initial analysis, the top-line data demonstrated that nasal
nalmefene achieved significantly higher plasma concentrations
compared to an intramuscular injection (p<0.0001). The time for
nasal nalmefene to achieve maximum plasma concentrations (Tmax) was
consistent with data from the previously completed pilot study (~15
minutes). The maximum plasma concentration (Cmax) was higher than
observed in the pilot study, and the plasma half-life of nasal
nalmefene (~11 hours) was consistent with reported values following
other routes (oral and parenteral) of administration. Naloxone,
currently the only FDA-approved treatment for opioid
overdose, has a half-life of approximately 2 hours.
“We are very pleased with the results of this confirmatory PK
study. Importantly, the data are consistent with the findings of
our initial pilot study,” said Roger Crystal, M.D., CEO and
President, of Opiant. “In the United States, where we’ve seen the
opioid epidemic worsen during COVID-19, the nationwide spread of
potent illicit synthetic opioids, such as fentanyl, which is 50
times stronger than heroin, with a half-life more than seven
hours1, is driving significant numbers of opioid overdose deaths. A
rescue agent with a rapid onset and a long half-life, is critical
to saving lives from overdose. We now look forward to the PD data
later in the year.”
In April, Opiant initiated a pharmacodynamic (“PD”) study in
healthy subjects comparing OPNT003 with nasal naloxone in reversing
the respiratory depression produced by the synthetic opioid,
remifentanil2. The Company anticipates the availability of top-line
data in the fourth quarter of 2021. Both PK and PD data will form
the basis of a New Drug Application submission using the 505(b)(2)
regulatory pathway previously agreed upon with the FDA by year
end, or first quarter 2022. The development of OPNT003 is supported
by grants from the National Institute on Drug Abuse, part of the
National Institutes of Health (“NIH”), and the Biological
Advance Research and Development Agency.
Deaths resulting from opioid overdose are at unprecedented
levels. Projections from the Centers for Disease Control and
Prevention report over 69,000 opioid overdose deaths in the 12
months through November 20203. Eighty percent, or 56,700 deaths,
are linked to potent illicit synthetic opioids, particularly
fentanyl. In 2017, the NIH leadership called for longer lasting and
stronger opioid overdose reversal agents in response to the potency
of synthetic opioids and to confront this escalating public health
crisis4.
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 regarding
the timing of receipt of PD data and the filing of an NDA for
OPNT003 and the drug candidate’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
- Ahonen J, Olkkola KT, Hynynen M, Seppälä T, Ikävalko H,
Remmerie B, Salmenperä M. Comparison of alfentanil, fentanyl and
sufentanil for total intravenous anaesthesia with propofol in
patients undergoing coronary artery bypass surgery. Br J Anaesth.
2000 Oct;85(4):533-40. doi: 10.1093/bja/85.4.533. PMID:
11064610.
-
https://clinicaltrials.gov/ct2/show/NCT04828005?term=opiant&draw=2&rank=1
- NCHS, National Vital Statistics System
- 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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