Opiant Pharmaceuticals, Inc. (Opiant) (NASDAQ: OPNT), a
specialty pharmaceutical company developing medicines to treat
addictions and drug overdose, today announced that the last patient
has been enrolled in the Phase 2 clinical trial of OPNT002, nasal
naltrexone, for patients with Alcohol Use Disorder (AUD). The total
trial duration per patient is 20 weeks, with the last patient
enrolled expected to complete the study in early 2023 and with top
line data anticipated to follow mid-year.
"We are pleased to have completed patient enrollment ahead of
schedule and are looking forward to concluding the treatment phase
of this study and releasing top-line data next year,” said Roger
Crystal, M.D., President and Chief Executive Officer of Opiant.
"This study is a critical step in our effort to develop alternative
therapeutic treatment options to improve the lives of people
suffering from alcohol use disorder."
Opiant launched its Phase 2 clinical study of OPNT002 for the
treatment of alcohol use disorder in January 2022. The
multi-center, double-blind, randomized, placebo-control Phase 2
study is being conducted in Europe, and is designed to evaluate
OPNT002 efficacy, safety, and tolerability in 300 patients with
AUD. The trial is being conducted using a Sequential Parallel
Comparison Study Design, which is useful in psychiatric studies to
reduce the impact of the placebo effect on the assessment of
treatment response. The primary end point will be measured by the
proportion of patients showing an improvement in World Health
Organization (WHO) Risk Levels of Alcohol Consumption consisting of
a 2-level reduction from baseline to end of treatment.
About OPNT002Clinical 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 products1.
Opiant is developing OPNT002 to rapidly increase plasma
concentrations of naltrexone 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.
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 WHO, harmful use of alcohol is responsible
for 5.1% of the global burden of disease4,5. A report by
the Centers for Disease Control and Prevention, found that
deaths from alcohol use increased by 43% from 2006 to 20186.
Currently, less than 10% of individuals with AUD seek treatment for
their drinking problems7, and many individuals with AUD who do not
seek alcohol treatment report not wanting to stop drinking as their
primary reason for not seeking treatment8. Individuals with AUD who
do not initially accept an abstinence goal may find treatment more
appealing if it is focused on reductions in drinking.
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 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,
2021, and our Form 10-Q for the quarters ended March 31, 2022 and
June 30, 2022, filed with the Securities and Exchange
Commission on March 4, 2022, May 10, 2022 and August 10,
2022, respectively, 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
1. 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. https://www.nature.com/articles/1301440
2. Krieter P, et al. Enhanced Intranasal
Absorption of Naltrexone by Dodecyl Maltopyranoside: Implications
for the Treatment of Opioid Overdose. Journal of Clinical
Pharmacology,
2019 https://www.opiant.com/wp-content/uploads/2019/05/2019-IN-NTX-J-Clin-Pharm-1.pdf3. Research
& Development Meeting on Emerging Therapeutics for the
Treatment of Addiction and Drug Overdose. Available at:
https://ir.opiant.com/events/event-details/research-development-meeting-emerging-therapeutics-treatment-addiction-and
4. National Institute on Alcohol Abuse and Alcoholism. Available
at: https://www.niaaa.nih.gov/alcohol-health/overview-alcohol-consumption/alcohol-use-disorders
5. World Health Organization. Available
at: https://www.who.int/health-topics/alcohol#tab=tab_16. Spencer,
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 20207. Grant BF, Goldstein
RB, Saha TD, Chou SP, Jung J, Zhang H, Pickering RP, Ruan WJ, Smith
SM, Huang B, Hasin DS. Epidemiology of DSM-5 Alcohol Use Disorder:
Results From the National Epidemiologic Survey on Alcohol and
Related Conditions III. JAMA Psychiatry. 2015 Aug;72(8):757-66.
doi: 10.1001/jamapsychiatry.2015.0584. PMID: 26039070; PMCID:
PMC5240584.
8. Figure 25 in
https://www.samhsa.gov/data/sites/default/files/NSDUH-DR-FRR3-2014/NSDUH-DR-FRR3-2014/NSDUH-DR-FRR3-2014.htm
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