Indivior Pharmaceuticals, Inc 6-K, filed Feb 24, 2025
Indivior Pharmaceuticals, Inc. (INDV)
6-K
2025-02-24
For: 2025-02-24
View Original
Added on
April 10, 2026
About this 6-K
Indivior Pharmaceuticals, Inc filed this 6-K on February 24, 2025.
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UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
________________________
Washington, D.C. 20549
_____________________
FORM 6-K
_____________________
Report of Foreign Private Issuer
Pursuant to Rule 13a-16 or 15d-16
under the Securities Exchange Act of 1934
For the month of February 2025
Commission File Number: 001-37835
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Indivior PLC
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10710 Midlothian Turnpike, Suite 125
North Chesterfield, Virginia 23235
(Address of principal executive office)
_______________________________
Indicate
by check mark whether the registrant files or will file annual
reports under cover of Form 20-F or Form 40-F
Form
20-F ☒ Form 40-F ☐
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EXHIBIT INDEX
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Exhibit No.
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Description of Exhibit
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99.1
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SIGNATURES
Pursuant
to the requirements of the Securities Exchange Act of 1934, the
registrant has duly caused this report to be signed on its behalf
by the undersigned, thereunto duly authorized.
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Indivior PLC
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Date: February 24,
2025
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/s/
Kathryn Hudson
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Name:
Kathryn Hudson
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Title:
Company Secretary
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Exhibit 99.1
Indivior Announces FDA Approval of Label Changes for
SUBLOCADE® (buprenorphine extended-release)
Injection
Rapid Initiation Protocol Reduces Time to Treatment with
SUBLOCADE® From One
Week to One Hour, A Significant Advancement in the Treatment of
Moderate to Severe Opioid Use Disorder (OUD)
Richmond, VA, February 24, 2025 - Indivior PLC (Nasdaq/LSE: INDV), a global
leader in addiction treatment, today announced that the U.S. Food
and Drug Administration (FDA) has approved label changes for
SUBLOCADE® including a rapid initiation protocol and
alternative injection sites, marking a significant advancement in
the treatment of moderate to severe opioid use disorder
(OUD).
Key Label Changes Include:
●
Rapid initiation
Protocol: Healthcare
providers can now initiate treatment with SUBLOCADE after a single
dose of transmucosal buprenorphine and a one-hour observation
period to confirm tolerability.1,2
●
Alternative Injection
Sites: SUBLOCADE can now
be administered subcutaneously in the abdomen, thigh, buttock, or
back of the upper arm, offering patients and healthcare providers
increased flexibility in treatment
administration2.
These FDA label changes can provide important benefits for patients
and healthcare providers. Rapid initiation may lessen some of the
practical obstacles to treatment induction, which may increase the
likelihood that patients and providers will start therapy quickly,
thereby shortening the time to achieve SUBLOCADE's therapeutic
levels that provide continuous buprenorphine concentrations above
2ng/mL.3
Additionally, the ability
to select a different injection site may provide patients
more flexibility so that they may be inclined to continue their
treatment. More options for healthcare providers to administer
SUBLOCADE will streamline the course of treatment and improve
integration into different healthcare
environments.
"These label updates for SUBLOCADE underscore our dedication to
evolving our treatment options to better serve individuals battling
opioid use disorder," said Dr. Christian Heidbreder, Ph.D., Chief
Scientific Officer at Indivior. "These enhancements not only
reflect our commitment to patient-centered care but also our
ongoing efforts to align our treatments with real-world clinical
needs, thereby potentially improving patient adherence and
outcomes."
Indivior is committed to empowering patients on their path to
recovery by providing treatments that are both effective and
tailored to their medical needs. These label changes do not alter
the well-established safety profile or the efficacy of SUBLOCADE
and the medication continues to offer an effective treatment option
for OUD while being more adaptable to patient medical
needs.
The non-inferiority study supporting rapid induction with SUBLOCADE
was conducted across multiple sites, included 729 participants
(mean age 40.7, average opioid use of 15 years)1, and
was stratified by fentanyl presence in urine screens. At induction
77.5% of patients were fentanyl-positive. Patients were randomized
at a 2:1 ratio to rapid initiation [received a single dose of 4 mg
transmucosal buprenorphine (TM-BUP), followed by a SUBLOCADE
injection within one hour] or to a standard induction (daily TM-BUP
over ≥7 days) before receiving injection 1. Rapid induction
was effective, shown by the primary endpoint of participant
retention at the second injection. The proportion of
participants who received the second injection was 66.4% in the
rapid induction arm and 54.5% in the standard induction
arm2.
About SUBLOCADE®
SUBLOCADE ® (buprenorphine extended-release) injection, for
subcutaneous use, CIII
INDICATION AND HIGHLIGHTED SAFETY INFORMATION
INDICATION
SUBLOCADE is indicated for the treatment of moderate to severe
opioid use disorder in patients who have initiated treatment with a
single dose of a transmucosal buprenorphine product or who are
already being treated with buprenorphine.
SUBLOCADE should be used as part of a complete treatment plan that
includes counseling and psychosocial support.
HIGHLIGHTED SAFETY INFORMATION
WARNING: RISK OF SERIOUS HARM OR DEATH WITH INTRAVENOUS
ADMINISTRATION; SUBLOCADE RISK EVALUATION AND MITIGATION
STRATEGY
● Serious
harm or death could result if administered intravenously.
SUBLOCADE forms a solid mass upon contact with body fluids and may
cause occlusion, local tissue damage, and thrombo-embolic events,
including life-threatening pulmonary emboli, if administered
intravenously.
● Because
of the risk of serious harm or death that could result from
intravenous self-administration, SUBLOCADE is only available
through a restricted program call the SUBLOCADE REMS
Program. Healthcare settings and pharmacies that order
and dispense SUBLOCADE must be certified in this program and comply
with the REMS requirements.
CONTRAINDICATIONS
Hypersensitivity to buprenorphine or any other ingredients in
SUBLOCADE.
WARNINGS AND PRECAUTIONS
Addiction, Abuse, and Misuse: SUBLOCADE contains buprenorphine, a Schedule
III controlled substance that can be abused in a manner similar to
other opioids. Monitor patients for conditions indicative of
diversion or progression of opioid dependence and addictive
behaviors.
Respiratory Depression: Life threatening respiratory depression and
death have occurred in association with buprenorphine. Warn
patients of the potential danger of self-administration of
benzodiazepines or other CNS depressants while under treatment with
SUBLOCADE.
Risk of Serious Injection Site Reactions: Likelihood of may increase with inadvertent
intramuscular or intradermal administration. Evaluate and treat as
appropriate. The most common injection site reactions are pain,
erythema and pruritus with some involving abscess, ulceration and
necrosis.
Neonatal Opioid Withdrawal Syndrome: Neonatal opioid withdrawal syndrome (NOWS)
is an expected and treatable outcome of prolonged use of opioids
during pregnancy.
Adrenal Insufficiency: If
diagnosed, treat with physiologic replacement of corticosteroids,
and wean patient off of the opioid.
Risk of Opioid Withdrawal with Abrupt
Discontinuation: If
treatment with SUBLOCADE is discontinued, monitor patients for
several months for withdrawal and treat
appropriately.
Risk of Hepatitis, Hepatic Events: Monitor liver function tests prior to and
during treatment.
Risk of Withdrawal in Patients Dependent on Full Agonist
Opioids: Verify that
patients have tolerated transmucosal buprenorphine before injecting
SUBLOCADE.
Treatment of Emergent Acute Pain: Treat pain with a non-opioid analgesic
whenever possible. If opioid therapy is required, monitor patients
closely because higher doses may be required for analgesic
effect.
ADVERSE REACTIONS
Adverse reactions commonly associated with SUBLOCADE (in ≥5%
of subjects) were constipation, headache, nausea, injection site
pruritus, vomiting, increased hepatic enzymes, fatigue, and
injection site pain.
For more information about SUBLOCADE, the full Prescribing
information including BOXED WARNING, and Medication Guide,
visit www.sublocade.com.
About Opioid Use Disorder (OUD)
Opioid Use Disorder (OUD) is a chronic disease in which people
develop a pattern of using opioids that can lead to negative
consequences.4 OUD
may affect the parts of the brain that are necessary for
life-sustaining functions.4
About Indivior
Indivior is a global pharmaceutical company working to help change
patients' lives by developing medicines to treat substance use
disorders (SUD). Our vision is that all patients around the world
will have access to evidence-based treatment for the chronic
conditions and co-occurring disorders of SUD. Indivior is dedicated
to transforming SUD from a global human crisis to a recognized and
treated chronic disease. Building on its global portfolio of OUD
treatments, Indivior has a pipeline of product candidates designed
to
expand on its heritage in this category.
Headquartered in the United States in Richmond, VA, Indivior
employs over 1,000 individuals globally and its portfolio of
products is available in over 30 countries worldwide.
Visit www.indivior.com to
learn more. Connect with Indivior on LinkedIn by
visiting www.linkedin.com/company/indivior.
Media Contact:
Cassie France-Kelly,
Cassie.france-kelly@indivior.com
References
1.
Data on File. Indivior Inc. North Chesterfield, VA.
2.
SUBLOCADE (buprenorphine extended-release) injection, for
subcutaneous use [package insert]. North Chesterfield, VA:
Indivior PLC; 2025.
3. Jones AK, Ngaimisi E, Gopalakrishnan M, Young MA,
Laffont CM. Population Pharmacokinetics of a Monthly Buprenorphine
Depot Injection for the Treatment of Opioid Use Disorder: A
Combined Analysis of Phase II and Phase Ill
Trials. Clin
Pharmacokinet. 2021;60(4):527-540.
doi:10.1007/s40262-020-00957-0.
4. NIDA.
2022, March 22. Drugs and the Brain. Accessed October
30,2023, from https://nida.nih.gov/publications/drugs-brains-behavior-science-addiction/drugs-brain