REG - Indivior PLC - FDA Approval of SUBLOCADE Label Changes

IndiviorAnnouncement

24/02/2025 07:00

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RNS Number : 1783Y  Indivior PLC  24 February 2025

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
administration(2).

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 arm(2).

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
(http://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
(https://c212.net/c/link/?t=0&l=en&o=4271839-1&h=3117038971&u=https%3A%2F%2Fc212.net%2Fc%2Flink%2F%3Ft%3D0%26l%3Den%26o%3D4245151-1%26h%3D1246464342%26u%3Dhttps%253A%252F%252Fwww.indivior.com%252Fen%26a%3Dwww.indivior.com&a=www.indivior.com)
 to learn more. Connect with Indivior on LinkedIn by
visiting www.linkedin.com/company/indivior
(https://c212.net/c/link/?t=0&l=en&o=4271839-1&h=2950697406&u=https%3A%2F%2Fc212.net%2Fc%2Flink%2F%3Ft%3D0%26l%3Den%26o%3D4245151-1%26h%3D27799095%26u%3Dhttp%253A%252F%252Fwww.linkedin.com%252Fcompany%252Findivior%26a%3Dwww.linkedin.com%252Fcompany%252Findivior.&a=www.linkedin.com%2Fcompany%2Findivior)
.

Media Contact:

Cassie France-Kelly,

Cassie.france-kelly@indivior.com (mailto: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
(https://c212.net/c/link/?t=0&l=en&o=4305830-1&h=1265300951&u=https%3A%2F%2Fc212.net%2Fc%2Flink%2F%3Ft%3D0%26l%3Den%26o%3D4271839-1%26h%3D2138115324%26u%3Dhttps%253A%252F%252Fnida.nih.gov%252Fpublications%252Fdrugs-brains-behavior-science-addiction%252Fdrugs-brain%26a%3Dhttps%253A%252F%252Fnida.nih.gov%252Fpublications%252Fdrugs-brains-behavior-science-addiction%252Fdrugs-brain&a=https%3A%2F%2Fnida.nih.gov%2Fpublications%2Fdrugs-brains-behavior-science-addiction%2Fdrugs-brain)

 

 

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