Opiant Pharmaceuticals Announces Positive Pharmacokinetic, Safety, and Tolerability Results From a Multi-Dose Study for OPNT003, Nasal Nalmefene
February 10 2022 - 8:00AM
Opiant Pharmaceuticals, Inc. (“Opiant”) (NASDAQ: OPNT) today
announced positive topline results from a multi-dose
pharmacokinetic (“PK”) study for OPNT003, nasal nalmefene, an
investigational treatment for opioid overdose. The crossover design
study was conducted in 23 healthy subjects comparing the PK
profile, safety, and tolerability of OPNT003 when given as a single
3mg dose in one nostril, as a single dose in each nostril, and as
two doses in one nostril.
Summary of topline results for OPNT003, nasal
nalmefene:
- Demonstrated rapid nasal absorption (Tmax 15 min) in all three
study arms
- Showed dose proportional plasma concentrations whether
administered as a single dose in each nostril or as two doses in a
single nostril
- Confirmed the long plasma half-life (t1/2 ~ 11 h) of
nalmefene
- Demonstrated nasal nalmefene is safe and well tolerated when
administered in multiple doses
Opiant carried out the study at the request of the U.S. Food and
Drug Administration (“FDA”) and will include these data as part of
its New Drug Application (“NDA”) submission this year.
“We are pleased that this study has met our objective of
demonstrating safety, tolerability, and pharmacokinetic equivalence
across multiple nasal doses,” said Roger Crystal, M.D.,
President and Chief Executive Officer of Opiant. “These data are
fully consistent with the rapid delivery of high plasma
concentrations of nalmefene observed in our previous OPNT003-PK-001
study, which compared 3 mg nasal nalmefene to a previously approved
intramuscular dose. We look forward to completing our assessment of
the potential of OPNT003 for treating opioid overdose with the
ongoing pharmacodynamic study comparing nasal nalmefene with nasal
naloxone.”
In 2021, the FDA granted Fast Track Designation to
OPNT003. Opiant is currently completing a pharmacodynamic
(“PD”) study comparing nasal nalmefene with nasal naloxone in
reversing respiratory depression produced by remifentanil, a
synthetic opioid. In a confirmatory PK study, conducted last year,
OPNT003 exhibited both rapid absorption (Tmax 15 min) and high
plasma concentrations (Cmax 12.2 ng/ml) that surpassed
intramuscular nalmefene, as well as a comparable long duration.
These are attributes that support OPNT003 as a potential major
advance in opioid overdose reversal. OPNT003 is being developed
using a 505(b)(2) pathway, with PK and PD studies supporting NDA
submission.
Opioid overdose is a significant public health crisis that has
been exacerbated by the increased availability and abuse of
synthetic opioids, such as fentanyl. In a 12-month period that
ended in June 2021, over 76,000 people in the U.S. died from an
opioid overdose1.
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
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inferred by these forward-looking statements, and among other
things, our ability to maintain cash balances and successfully
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"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.
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.
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