RICHMOND, Va., Sept. 26, 2019 /PRNewswire/ -- Indivior PLC
(LON: INDV) announces that the National Institutes of Health (NIH)
has granted Indivior's application entitled "Clinical
Evaluation of C4X3256, a Non-Opioid, Highly-Selective Orexin-1
Receptor Antagonist for the Treatment of Opioid Use Disorder"
pursuant to Funding Opportunity Announcement RFA-DA-19-002
dedicated to the development of medications to prevent and treat
opioid use disorder and overdose.
Indivior's award is one of 375 grant awards across 41 states
made by the NIH in fiscal year 2019 to apply scientific solutions
to reverse the national opioid crisis. The National Institutes of
Health launched the Helping to End Addiction Long-term Initiative,
or NIH HEAL Initiative, in April 2018
to improve prevention and treatment strategies for opioid misuse
and addiction and enhance pain management.
"It's clear that a multi-pronged scientific approach is needed
to reduce the risks of opioids, accelerate development of effective
non-opioid therapies for pain and provide more flexible and
effective options for treating addiction to opioids," said NIH
Director Francis S. Collins, M.D.,
Ph.D., who launched the initiative in early 2018. "This
unprecedented investment in the NIH HEAL Initiative demonstrates
the commitment to reversing this devastating crisis."
"Despite the availability of medications to treat opioid use
disorder, there is a need for improved treatment modalities that
involve new mechanisms of action," said Christian Heidbreder, Ph.D., Indivior's Chief
Scientific Officer. "C4X3256 is a novel non-opioid,
highly-selective orexin-1 receptor (OX1R) antagonist, suitable for
development for the treatment of opioid use disorder. With this
award, we will advance C4X3256 from preclinical status through
Phase 1 clinical evaluation and perform the necessary toxicology
and drug metabolism studies to enable Phase 2 studies."
In March 2018, Indivior entered
into a license agreement with C4X Discovery Holdings PLC (C4X)
whereby Indivior obtained exclusive global rights to develop and
commercialize C4X3256.
About Opioid Use Disorder
(OUD)
Opioid use disorder (OUD), sometimes
referred to as opioid addiction, is a chronic disease.1
According to DSM-5, "OUD is characterized by signs and symptoms
that reflect compulsive, prolonged self-administration of opioid
substances that are used for no legitimate medical purpose or, if
another medical condition is present that requires opioid
treatment, they are used in doses greatly in excess of the amount
needed for that medical condition."2
In 2018, an estimated 10.3 million people aged 12 or older
misused opioids in the past year, including 9.9 million
prescription pain reliever misusers and 808,000 heroin users.
Approximately 506,000 people misused prescription pain relievers
and used heroin in the past year.3
About Indivior
Indivior is a global specialty
pharmaceutical company with a 20-year legacy of leadership in
patient advocacy and health policy while providing education on
evidence-based treatment models that have revolutionized modern
addiction treatment. Our vision is for all patients around the
world to have access to evidence-based treatment for the chronic
conditions and co-occurring disorders of addiction. The name is the
fusion of the words individual and endeavor, and the tagline "Focus
on you" makes the Company's commitment clear. Indivior is dedicated
to transforming addiction from a global human crisis to a
recognized and treated chronic disease. Building on its global
portfolio of opioid dependence treatments, Indivior has a strong
pipeline of product candidates designed to both expand on its
heritage in this category and address other chronic conditions and
co-occurring disorders of addiction, including alcohol use disorder
and schizophrenia. Headquartered in the
United States in Richmond,
VA, Indivior employs more than 800 individuals globally and
its portfolio of products is available in over 40 countries
worldwide. Visit www.indivior.com to learn more. Connect with
Indivior on LinkedIn by visiting
www.linkedin.com/company/indivior.
Forward-Looking Statements
This press release contains
certain statements that are forward-looking and which should be
considered, amongst other statutory provisions, in light of the
safe harbor provisions of the United States Private Securities
Litigation Reform Act of 1995. By their nature, forward-looking
statements involve risk and uncertainty as they relate to events or
circumstances that may or may not occur in the future. Actual
results may differ materially from those expressed or implied in
such statements because they relate to future events.
Forward-looking statements include, among other things, statements
regarding the Indivior Group's financial guidance for 2019 and its
medium- and long-term growth outlook, its operational goals, its
product development pipeline and statements regarding ongoing
litigation.
Various factors may cause differences between Indivior's
expectations and actual results, including: factors affecting sales
of Indivior Group's products; the outcome of research and
development activities; decisions by regulatory authorities
regarding the Indivior Group's drug applications; the speed with
which regulatory authorizations, pricing approvals and product
launches may be achieved; the outcome of post-approval clinical
trials; competitive developments; difficulties or delays in
manufacturing; the impact of existing and future legislation and
regulatory provisions on product exclusivity; trends toward managed
care and healthcare cost containment; legislation or regulatory
action affecting pharmaceutical product pricing, reimbursement or
access; claims and concerns that may arise regarding the safety or
efficacy of the Indivior Group's products and product candidates;
risks related to legal proceedings, including the ongoing
investigative and antitrust litigation matters; the Indivior
Group's ability to protect its patents and other intellectual
property; the outcome of patent infringement litigation relating to
Indivior Group's products, including the ongoing ANDA lawsuits;
changes in governmental laws and regulations; issues related to the
outsourcing of certain operational and staff functions to third
parties; uncertainties related to general economic, political,
business, industry, regulatory and market conditions; and the
impact of acquisitions, divestitures, restructurings, internal
reorganizations, product recalls and withdrawals and other unusual
items.
This press release does not constitute an offer to sell or the
solicitation of an offer to subscribe for or otherwise acquire or
dispose of shares in the Company to any person in any jurisdiction
to whom it is unlawful to make such offer or solicitation.
References
- SUBLOCADE™ [Prescribing Information]. Indivior Inc.,
North Chesterfield, VA.
March 2018.
- American Psychiatric Association. (2013). Diagnostic and
Statistical Manual of Mental Disorders (5th ed.). Arlington, VA: American Psychiatric
Publishing.
- Substance Abuse and Mental Health Services Administration.
(2019). Key substance use and mental health indicators in
the United States: Results from
the 2018 National Survey on Drug Use and Health (HHS
Publication No. PEP19-5068, NSDUH Series H-54). Rockville, MD: Center for Behavioral Health
Statistics and Quality, Substance Abuse and Mental Health Services
Administration. Retrieved from https://www.samhsa.gov/data/
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SOURCE Indivior PLC