- Data show rapid initiation with once-monthly SUBLOCADE
significantly improves retention in opioid use disorder (OUD)
patients, especially among fentanyl-positive participants. Study
also administered second SUBLOCADE injection a week later vs.
standard 28 days, enabling patients to achieve and maintain target
medication levels more quickly.
- Presented at the 2024 Canadian Society of Addiction Medicine
(CSAM) conference, this study highlights the potential of rapid
initiation to transform the treatment of opioid use disorder.
- Data supporting the subcutaneous administration
of SUBLOCADE to alternative injection sites including the
thigh, upper arm, and buttocks vs current subcutaneous abdominal
injection site, were also presented at CSAM.
- SUBLOCADE has received Priority Review designation from
the U.S. Food and Drug Administration (FDA) to expand the label to
include rapid initiation one hour after a single transmucosal
buprenorphine dose as well as inclusion of alternative injection
sites.
RICHMOND, Va., Nov. 19,
2024 /PRNewswire/ -- Indivior PLC (Nasdaq/LSE: INDV)
last week shared results from a randomized, open-label sub-study in
opioid-dependent participants seeking treatment, (NCT04995029) that
demonstrates rapid initiation (RI) with SUBLOCADE®
(buprenorphine extended-release injection) for the treatment of OUD
significantly improves treatment retention compared to standard
initiation (SI). RI with SUBLOCADE in a single day may reduce
barriers to treatment and improve patient retention especially
those who frequently inject opioids or use fentanyl without
increasing the risk of precipitated opioid withdrawal (POW)
symptoms. The data were presented at the 2024 Canadian Society of
Addiction Medicine (CSAM) conference in Hamilton, Ontario, Canada.
"These findings underscore the potential for rapid initiation to
transform opioid use disorder treatment," said Dr. Christian Heidbreder, Ph.D., Chief Scientific
Officer at Indivior. "Rapid initiation may improve patient
retention and meet the immediate needs brought on by synthetic
opioids in real-world settings, offering a practicable path to
stabilization and long-lasting, meaningful recovery."
Conducted across multiple sites, this non-inferiority study
included 729 participants (mean age 42, average opioid use of 15
years), stratified by fentanyl presence in urine screens, with an
observed 78% fentanyl-positive rate. Patients randomized to RI
received a single dose of 4 mg transmucosal buprenorphine (TM-BUP),
followed by a SUBLOCADE injection within 1 hour. The primary
endpoint was treatment retention at injection 2, administered 1
week after injection 1 comparing it to the current standard regimen
of 28 days. Those in the SI group received daily TM-BUP doses over
≥7 days before injection, and if non-inferiority was met,
superiority was assessed.
Among the participants, RI was superior to SI in retention rates
at injection 2, with a 12% improvement overall and 15% in the
fentanyl-positive group. The shorter dose interval between BUP-XR
injection 1 and 2 was designed to achieve and maintain
buprenorphine plasma concentrations more quickly at target levels
of 2 ng/mL. The overall Treatment Emergent Adverse Events (TEAE)
profile up to Injection 2 was comparable for RI and SI. There
were no unexpected safety findings.
Data supporting the subcutaneous administration of SUBLOCADE to
alternative injection sites including the thigh, upper arm, and
buttocks were also presented at CSAM (NCT04995029).
SUBLOCADE has received Priority Review designation granted by
the U.S. Food and Drug Administration (FDA) for a labeling
supplement, which would expand the label to include rapid
initiation one hour after a single transmucosal buprenorphine dose
and also expands from the current subcutaneous abdominal injection
site for induction and maintenance to alternative injection sites
including the thigh, upper arm, and buttocks. With a Prescription
Drug User Fee Act (PDUFA) action date set for February 7, 2025, this Prior Approval Supplement
(PAS) submission, if approved, could allow healthcare providers a
flexible approach to initiate treatment rapidly, supporting better
retention outcomes for OUD patients, particularly those testing
positive for fentanyl. A Priority Review designation means that the
FDA's goal is to take action on an application within 6 months
(compared to 10 months under standard review). If approved, this
label change could translate into significant improvements in OUD
treatment with SUBLOCADE.
This press release has been issued by Indivior Inc. and the
content has not been approved or authorized by the Canadian Society
of Addiction Medicine.
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
buprenorphine-containing product, followed by dose adjustment for a
minimum of 7 days.
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 called 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
SUBLOCADE should not be administered to patients who have been
shown to be hypersensitive to buprenorphine or any component of
Indivior's proprietary buprenorphine gel depot delivery system.
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.
Opioids can cause sleep-related breathing disorders e.g.,
central sleep apnea (CSA), sleep-related hypoxemia. Opioid use
increases the risk of CSA in a dose-dependent fashion. Consider
decreasing the opioid using best practices for opioid taper if CSA
occurs.
Strongly consider prescribing naloxone at SUBLOCADE initiation
or renewal because patients being treated for opioid use disorder
have the potential for relapse, putting them at risk for opioid
overdose. Educate patients and caregivers on how to recognize
respiratory depression and how to treat with naloxone if
prescribed.
Risk of Serious Injection Site Reactions: The most common
injection site reactions are pain, erythema and pruritus with some
involving abscess, ulceration, and necrosis. The likelihood of
serious injection site reactions may increase with inadvertent
intramuscular or intradermal administration.
Neonatal Opioid Withdrawal Syndrome: Neonatal opioid withdrawal
syndrome 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 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 patient is clinically stable on
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.1 OUD may affect the parts of the
brain that are necessary for life-sustaining
functions.1,2
Important Cautionary Note Regarding Forward-Looking
Statements
This press release contains certain statements that are
forward-looking. Forward-looking statements include, among other
things, express and implied statements regarding: Indivior PLC's
expectations regarding the timing of approval for the PAS for rapid induction and injection
sites, and the potential impact on OUD treatments and Sublocade
from such; and other statements containing the words "believe,"
"anticipate," "plan," "expect," "expectations," "intend,"
"estimate," "forecast," "strategy," "target," "guidance,"
"outlook," "potential," "project," "priority," "may," "will,"
"should," "would," "could," "can," the negatives thereof, and
variations thereon and similar expressions. By their nature,
forward-looking statements involve risks and uncertainties 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 these forward-looking statements due to a number of
factors, including: failure or delay in obtaining approval of
the PAS and the acceptance by HCPs
and their patients of the perceived benefits of such PAS changes.
For information about some of the risks and important factors that
could affect our future results and financial condition, see "Risk
Factors" in Indivior's Annual Report on Form 20-F for the fiscal
year 2023 and its other filings with the U.S. Securities and
Exchange Commission. We have based the forward-looking statements
in this press release on our current expectations and beliefs
concerning future events. Forward-looking statements contained in
this press release apply only at the date of this press release
and, except as required by law, we undertake no obligation to
update or revise any forward-looking statement, whether due to new
information, future developments, or otherwise.
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.
References
- National Academies of Sciences, Engineering, and Medicine;
Health and Medicine Division; Board on Health Sciences Policy;
Committee on Medication-Assisted Treatment for Opioid Use
Disorder, Mancher, M., & Leshner, A. I. (Eds.).
(2019). Medications for Opioid Use Disorder Save Lives.
National Academies Press (US). Accessed October 30, 2023,
from https://www.ncbi.nlm.nih.gov/books/NBK538936/pdf/Bookshelf_NBK538936.pdf
- 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
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