Opiant Pharmaceuticals Announces First Patient Dosed in Phase 2 Trial of OPNT002, Nasal Naltrexone, for Alcohol Use Disorder
Opiant Pharmaceuticals, Inc. (“Opiant”) (NASDAQ: OPNT) today
announced that the first patient has been dosed in a Phase 2
clinical trial of OPNT002, nasal naltrexone, for the treatment of
Alcohol Use Disorder (“AUD”). The trial will determine whether
OPNT002 reduces heavy drinking as measured by a change in the World
Health Organization (“WHO”) drinking risk levels1.
“The development of OPNT002 is predicated on modifying a
patient’s drinking behavior in order to reduce the harm of
alcohol,” said Phil Skolnick, Ph.D., D.Sc. (hon.), Chief Scientific
Officer of Opiant. “Compelling clinical data have shown that
reducing drinking from very high levels to more moderate levels can
reduce long-term mortality and overall disease burden.”
Clinical and preclinical studies have shown that alcohol
releases endorphins, which are the brain’s endogenous opioids.
These endorphins are thought to activate opioid receptors, which
contribute to alcohol’s reinforcing and addictive properties.
Current naltrexone treatments work to block mu-opioid receptors
when administered orally or through injection. However, converging
lines of evidence indicate that activation of delta-opioid
receptors also contributes to the reinforcing properties of
alcohol. The effective blockade of delta‐opioid receptors requires
much higher plasma naltrexone concentrations than is achieved by
currently approved naltrexone products5.
Opiant is developing OPNT002 to rapidly increase plasma
concentrations of the drug following dosing and thereby block mu
and delta-opioid receptors. In previous research, OPNT002 has
demonstrated rapid nasal absorption, delivering high levels of
naltrexone yet with a short half-life. Results from Phase 1 studies
demonstrate that OPNT002 produces maximum plasma concentrations
that are approximately 50% higher than orally administered
naltrexone. This feature, along with a very rapid onset and a short
plasma half-life, are characteristics ideally suited to developing
OPNT002 for ‘as needed’ nasal dosing in anticipation of drinking,
or once drinking has started2,3. The primary end point will be the
proportion of subjects showing an improvement in WHO Drinking Risk
Level consisting of a 2-level reduction from Baseline to end of
treatment. WHO Drinking Risk Level will be evaluated in the 28 days
prior to the Baseline and end of treatment visits.
The trial is a randomized, double-blind, placebo-controlled
study that will enroll approximately 300 patients at sites within
the European Union and the United Kingdom. The trial features a
Sequential Parallel Comparison Study Design (“SPCD”) aiming to
reduce placebo response. Results from the trial are expected in
“Multiple medications are approved for the treatment of AUD, yet
less than 10% of individuals with AUD currently receive treatment,”
said Roger Crystal MD, President and Chief Executive Officer of
Opiant. “For those suffering from AUD, current therapies and
treatments are built around an endpoint of abstinence, rather than
harm reduction. The availability of a treatment option in the event
a person craves alcohol, anticipates drinking or finds themselves
in a high-risk situation such as a party or restaurant setting is
an approach we believe could increase the number of people using
About Alcohol Use DisorderAlcohol Use Disorder
is a chronic relapsing brain disease characterized by compulsive
use of alcohol and the inability to control intake. It is the third
leading preventable cause of death in the United States, and
according to the World Health Organization, harmful use of alcohol
is responsible for 5.1% of the global burden of disease6,7. A
report by the Centers for Disease Control and Prevention, found
that deaths from alcohol use increased by 43 percent from 2006 to
20188. Another study published in the JAMA network about changes in
alcohol use during the COVID-19 pandemic said compared to 2019,
American adults have increased their alcohol intake in 2020, by 14
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
Forward-Looking StatementsThis press release
contains forward-looking statements, including the anticipated
results of the Phase 2 study in 2023. 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.
For Media and Investor Inquiries:Ben Atkins, Opiant(310)
1. Witkiewitz, K et al. Drinking Risk Level
Reductions Associated with Improvements in Physical Health and
Quality of Life Among Individuals with Alcohol Use Disorder.
Alcoholism: Clinical and Experimental Research 42(12):2453-2465,
20182. Krieter P, et al. Enhanced Intranasal
Absorption of Naltrexone by Dodecyl Maltopyranoside: Implications
for the Treatment of Opioid Overdose. Journal of Clinical
& Development Meeting on Emerging Therapeutics for the
Treatment of Addiction and Drug Overdose. Available at:
AF, Heilig M, Perez A, Probst C, Rehm J. Alcohol use disorders.
Lancet. 2019 Aug 31;394(10200):781-792. doi:
31478502.5. Weerts E, Kim Y, Wand G, et al.
Differences in δ and μ opioid receptor blockade measured by
positron emission tomography in naltrexone-treated recently
abstinent alcohol-dependent subjects. Neuropsychopharm.
2008;33:653-665. 6. National Institute on Alcohol
Abuse and Alcoholism. Available at:
7. World Health Organization. Available at:
M et al. Rates of Alcohol-induced Deaths Among Adults Aged 25 and
Over in Urban and Rural Areas: United States, 2000–2018, NCHS Data
Brief No. 383, October 20209. Pollard, M et al.
Changes in Adult Alcohol Use and Consequences During the COVID-19
Pandemic in the US. Jama Network doi:
10.1001/jamanetworkopen.2020.22942, Sept 2020
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