- PDUFA date set for February 7,
2025
- If approved by the FDA, label would expand to include
alternative injection sites in the thigh, buttock and back of the
arm for induction and maintenance as well as rapid induction one
hour after a single transmucosal buprenorphine dose; both of
which address significant patient and healthcare provider unmet
needs.
RICHMOND, Va., Oct. 7, 2024
/PRNewswire/ -- Indivior PLC (Nasdaq/LSE: INDV) today announced the
Prior Approval Supplement (PAS) for SUBLOCADE®
(buprenorphine extended-release) injection submitted by Indivior,
Inc. has been granted Priority Review designation by the U.S. Food
and Drug Administration (FDA). The Prescription Drug User Fee Act
(PDUFA) action date for this submission is set for February 7, 2025.
SUBLOCADE, Indivior's monthly injectable formulation of
buprenorphine for the treatment of moderate to severe opioid use
disorder (OUD), is the foundation of Indivior's portfolio of
innovative treatments aimed at transforming how the chronic
condition of OUD is managed. This PAS seeks to further expand
treatment options via two proposed updates to the SUBLOCADE label,
including:
- Alternative Injection Sites: Expands from the current
subcutaneous abdominal injection site to also include the thigh,
buttock, and back of the upper arm subcutaneously for induction and
maintenance.
- Rapid Induction Protocol:
- Reduces treatment induction time from the current 7-day minimum
on transmucosal buprenorphine (TM BUP) to a single dose of TM BUP
with 1-hour observation period to confirm tolerability.
- Allows for the second 300 mg dose to be administered as early
as one week after the initial 300 mg injection, based on patient
needs.
Indivior's PAS included comprehensive data which we believe
demonstrate the efficacy and safety of the new rapid induction
protocol and SUBLOCADE's pharmacokinetic profile following
injection at alternative sites. These updates are expected to
enhance the patient experience and expand treatment access
especially for those patients who, similar to the study
participants, have long-term opioid use including 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) and, if approved, would translate into
significant improvements in OUD treatment with SUBLOCADE.
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 news release contains certain statements that are
forward-looking. Forward-looking statements include, among other
things, express and implied statements regarding: whether the FDA
will approve the PAS which would allow us to update our label; the
safety and efficacy of the new rapid induction protocol and
alternative injection sites; enhanced patient experience, and
expanded patient access and other statements containing the words
"believe," "anticipate," "plan," "expect," "intend," "estimate,"
"forecast," "strategy," "target," "guidance," "outlook,"
"potential," "project," "priority," "may," "will," "should,"
"would," "could," "can," "outlook," "guidance," 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 because they
relate to future events. Various factors may cause differences
between Indivior's expectations and actual results, including,
among others, the fact that the regulatory approval process is
uncertain and may prevent us from obtaining approvals for some or
all of our product candidate; the FDA or other regulatory agencies
may not agree with our regulatory approval strategies or components
of our filings for our products and may not approve, or may delay
the approval of, our products; and the risks described in our most
recent annual report on Form 20-F beginning on page 9 as filed with
the U.S. SEC and in subsequent releases.
Forward-looking statements speak only as of the date that they
are made and should be regarded solely as our current plans,
estimates and beliefs. Except as required by law, we do not
undertake and specifically decline any obligation to update,
republish or revise forward-looking statements to reflect future
events or circumstances or to reflect the occurrences of
unanticipated events.
About Indivior
Indivior is a global pharmaceutical company working to help
change patients' lives by developing medicines to treat substance
use disorders (SUD), overdose and serious mental illnesses. 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 both
expand on its heritage in this category
and potentially address
other chronic conditions and co-occurring disorders
of SUD. 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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SOURCE Indivior PLC