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
