TIDMINDV
RNS Number : 4157G
Indivior PLC
01 March 2018
SUBLOCADE(TM) (Buprenorphine Extended-Release) is Now Available
as First and Only Monthly Injectable Buprenorphine in the U.S. to
Treat Patients with Moderate to Severe Opioid Use Disorder
Indivior launches new support services dedicated to helping
streamline the access process
on behalf of patients
Slough, UK and Richmond, VA, 1 March 2018 - Indivior PLC (LON:
INDV) today announced that SUBLOCADE(TM) (buprenorphine
extended-release) injection, for subcutaneous use (CIII), is now
available in the United States. SUBLOCADE is approved by the U.S.
Food and Drug Administration (FDA) for the treatment of moderate to
severe opioid use disorder (OUD) in adult patients who have
initiated treatment with a transmucosal buprenorphine-containing
product followed by dose adjustment for a minimum of seven days. It
should be administered only by healthcare providers and should be
used as part of a complete treatment program that includes
counseling and psychosocial support(1) .
"We're committed to helping the patients, families and
communities impacted by the opioid epidemic, and delivering new
treatment options for moderate to severe opioid use disorder," said
Richard Simkin, Chief Commercial and Strategy Officer of Indivior.
"The availability of SUBLOCADE, with our comprehensive support
services, marks a pivotal milestone for our company."
Medication-assisted treatments (MATs) for OUD may reduce the
illicit use of opioids. These therapies can be beneficial for
blocking the euphoric effects of mu-opioid receptor agonists(2)
.
The FDA approval of SUBLOCADE was based on data from a 24-week,
pivotal double blind, placebo-controlled Phase 3 study
(RB-US-13-0001) in which patients (n=504) who met DSM-5 criteria
for moderate to severe OUD were randomized to one of three
treatment regimens evaluating SUBLOCADE 300 mg, SUBLOCADE 100 mg
and placebo, in combination with individualized drug counseling
(IDC). Patients were randomized to SUBLOCADE injection or placebo
after withdrawal symptoms were clinically controlled following
treatment initiation with a transmucosal buprenorphine-containing
product. Efficacy was evaluated from weeks 5 through 24 based on
weekly urine drug screens combined with self-reported use of
illicit opioid use. The proportion of patients achieving treatment
success (defined as patients with >=80% opioid--free weeks) was
statistically significantly higher in both groups receiving
SUBLOCADE compared to the placebo group (28.4% [300 mg/100 mg],
29.1% [300 mg/300 mg], 2% [placebo])(1) .
SUBLOCADE has a BOXED WARNING and will be distributed through a
restricted distribution system, to ensure that SUBLOCADE is only
administered by a healthcare provider. Serious harm or death could
result if SUBLOCADE is 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.
SUBLOCADE will only be available through restricted distribution
under the SUBLOCADE Risk Evaluation and Mitigation Strategy (REMS)
Program.
Pursuant to the SUBLOCADE REMS, all healthcare settings and
pharmacies that order and dispense SUBLOCADE must be certified and
establish processes and procedures to verify the medication is
dispensed directly to a healthcare provider for administration by a
healthcare provider and is not dispensed directly to the patient.
Moreover, certified healthcare settings and pharmacies must not
distribute, transfer, loan, or sell SUBLOCADE(1) .
The systemic safety profile for SUBLOCADE, given by healthcare
providers in clinical trials, was consistent with the known safety
profile of transmucosal buprenorphine, except for injection site
reactions. Common adverse reactions (>=5% patients) included
constipation, nausea, vomiting, abnormal liver enzymes, headache,
sedation, somnolence and fatigue. Injection site reactions were
reported in 16.5% of the patients. None of the injection site
reactions were serious and one led to study treatment
discontinuation(1) .
Understanding that patients often have challenges accessing
treatment, Indivior has also launched INSUPPORT(TM) , an
interactive service to help streamline the access processes on
behalf of patients seeking treatment with all Indivior products.
INSUPPORT provides online and telephone resources for both patients
and healthcare providers, including a copay assistance program,
provider locator tool and information for providers' office staff.
For more information on these support services visit
www.INSUPPORT.com.
The opioid epidemic in the U.S. is a national public health
emergency(3) . Patients going through the treatment journey are
often faced with many barriers such as social stigma, access to
treatment and prescribers, and difficulty adhering to treatment
plans(4) .
"Patients struggle with addiction, and with an average of 115
people dying of opioid overdose per day in 2016(5) , the need for
more treatment options to help address this public health emergency
is dire," said Amit Vijapura, M.D., psychiatrist, and a SUBLOCADE
principal investigator. "I participated in the clinical trial
program for SUBLOCADE, and I am glad SUBLOCADE is now an available
option for patients with moderate to severe opioid use
disorder."
SUBLOCADE is available through waivered healthcare providers
under the Drug Addiction Treatment Act (DATA) codified at 21 U.S.C.
823(g), prescription use of SUBLOCADE in the treatment of opioid
dependence is limited to healthcare providers who meet certain
qualifying requirements, and who have notified the Secretary of
Health and Human Services (HHS) of their intent to prescribe this
product for the treatment of opioid dependence and have been
assigned a unique identification number that must be included on
every prescription(1) .
For further product information, see full Prescribing
Information including BOXED WARNING and Medication Guide at
www.SUBLOCADE.com.
About SUBLOCADE(TM)
INDICATION AND USAGE
SUBLOCADE is indicated for the treatment of moderate to severe
opioid use disorder in patients who have initiated treatment with a
transmucosal buprenorphine-containing product followed by a dose
adjustment period for a minimum of seven days.
SUBLOCADE should be used as part of a complete treatment program
that includes counseling and psychosocial support.
IMPORTANT SAFETY INFORMATION
Prescription use of this product is limited under the Drug
Addiction Treatment Act.
CONTRAINDICATIONS
SUBLOCADE should not be administered to patients who have been
shown to be hypersensitive to buprenorphine or any component of the
ATRIGEL(R) 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.
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 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 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.
About Opioid Use Disorder (OUD)
Opioid use disorder (OUD), sometimes referred to as opioid
addiction, is a chronic disease(1) . According to DSM-5, OUD is
characterized by signs and symptoms that reflect compulsive,
prolonged self-administration of opioid substances that are used
for no legitimate medical purpose or, if another medical condition
is present that requires opioid treatment, they are used in doses
greatly in excess of the amount needed for that medical
condition(6) .
Based on 2016 data from the National Survey on Drug Use and
Health report, nearly 11.8 million Americans (age 12+ years)
engaged in misuse of opioids in the last year(7) . Between 1999 and
2016 the rate of deadly prescription opioid overdoses increased
five-fold(8) , and in the United States alone, an average of 115
people died of opioid overdose per day in 2016(5) . In 2015 opioids
accounted for 70 percent of the disease burden associated with drug
use disorders worldwide(9) . In addition, 935,000 adults have used
heroin in the past year and 472,000 used in the past month(7) .
There were approximately 625,000 adults who had a heroin use
disorder in the past year(7) .
About Indivior
Indivior is a global specialty pharmaceutical company with a
20-year legacy of leadership in patient advocacy and health policy
while providing education on evidence-based treatment models that
have revolutionized modern addiction treatment. Our vision is that
all patients around the world have access to evidence-based
treatment for the chronic condition and co-occurring disorders of
addiction. The name is the fusion of the words individual and
endeavour, and the tagline "Focus on you" makes the Company's
commitment clear. Indivior is dedicated to transforming addiction
from a global human crisis to a recognized and treated chronic
disease. Building on its global portfolio of opioid dependence
treatments, Indivior has a strong pipeline of product candidates
designed to both expand on its heritage in this category and
address other chronic conditions and co-occurring disorders of
addiction, including alcohol use disorder and schizophrenia.
Headquartered in the United States in Richmond, VA, Indivior
employs more than 900 individuals globally and its portfolio of
products is available in over 40 countries worldwide. Visit
www.indivior.com to learn more.
Forward-Looking Statements
This press release contains certain statements that are
forward-looking and which should be considered, amongst other
statutory provisions, in light of the safe harbour provisions of
the United States Private Securities Litigation Reform Act of 1995.
By their nature, forward-looking statements involve risk and
uncertainty as they relate to events or circumstances that will or
may occur in the future. Actual results may differ materially from
those expressed or implied in such statements because they relate
to future events. Forward-looking statements include, among other
things, statements regarding our financial guidance for 2017 and
our medium- and long-term growth outlook, our operational goals,
our product development pipeline and statements regarding ongoing
litigation.
Various factors may cause differences between Indivior's
expectations and actual results, including: factors affecting sales
of Indivior Group's products; the outcome of research and
development activities; decisions by regulatory authorities
regarding the Indivior Group's drug applications; the speed with
which regulatory authorizations, pricing approvals and product
launches may be achieved; the outcome of post-approval clinical
trials; competitive developments; difficulties or delays in
manufacturing; the impact of existing and future legislation and
regulatory provisions on product exclusivity; trends toward managed
care and healthcare cost containment; legislation or regulatory
action affecting pharmaceutical product pricing, reimbursement or
access; claims and concerns that may arise regarding the safety or
efficacy of the Indivior Group's products and product candidates;
risks related to legal proceedings; the Indivior Group's ability to
protect its patents and other intellectual property; the outcome of
patent infringement litigation relating to Indivior Group's
products, including the ongoing ANDA lawsuits; changes in
governmental laws and regulations; issues related to the
outsourcing of certain operational and staff functions to third
parties; uncertainties related to general economic, political,
business, industry, regulatory and market conditions; and the
impact of acquisitions, divestitures, restructurings, internal
reorganizations, product recalls and withdrawals and other unusual
items.
This press release does not constitute an offer to sell or the
solicitation of an offer to subscribe for or otherwise acquire or
dispose of shares in the Company to any person in any jurisdiction
to whom it is unlawful to make such offer or solicitation.
References
1. SUBLOCADE label
2. Nasser AF et al. (2016). Sustained-Release Buprenorphine
(RBP-6000) Blocks the Effects of Opioid Challenge with
Hydromorphone in Subjects with Opioid Use Disorder. J Clin
Psychopharmacol. 36(1):18-26.
3. White House Council of Economic Advisers. (2017). The
Underestimated Cost of the Opioid Crisis. Retrieved from
https://www.whitehouse.gov/sites/whitehouse.gov/files/images/The%20Underestimated%20Cost%20of%20the%20Opioid%20Crisis.pdf.
Accessed November 20, 2017.
4. Providers' Clinical Support System For Medication Assisted
Treatment. (2017). Barriers to Treatment. Retrieved from
https://pcssmat.org/opioid-resources/barriers-to-treatment/.
Accessed January 12, 2018.
5. Centers for Disease Control and Prevention. Understanding the Epidemic. Retrieved from https://www.cdc.gov/drugoverdose/epidemic/index.html. Accessed October 28, 2017.
6. American Psychiatric Association. (2013). Diagnostic and
statistical manual of mental disorders (5th ed.). Arlington, VA:
American Psychiatric Publishing.
7. Substance Abuse and Mental Health Services Administration.
(2017). Key substance use and mental health indicators in the
United States: Results from the 2016 National Survey on Drug Use
and Health (HHS Publication No. SMA 17-5044, NSDUH Series H-52).
Rockville, MD: Center for Behavioral Health Statistics and Quality,
Substance Abuse and Mental Health Services Administration.
Retrieved from https://www.samhsa.gov/data/. Accessed September 11,
2017.
8. Centers for Disease Control and Prevention. (2017).
Prescription Opioid Overdose Data. Retrieved from:
https://www.cdc.gov/drugoverdose/data/overdose.html. Accessed
September 28, 2017.
9. United Nations Office on Drugs and Crime, World Drug Report
2017 (ISBN: 978-92-1-148291-1, eISBN: 978-92-1-060623-3, United
Nations publication, Sales No. E.17.XI.6).
Media Contacts
US
IndiviorMediaContacts@indivior.com
+1 804-594-0836
UK
Tulchan Communications
+44 207 353 4200
Investor Contact
Jason Thompson, Indivior
Vice President, Investor Relations
+1 804-423-8916
Jason.thompson@indivior.com
SUBLOCADE is a trademark of Indivior UK Limited.
(c) Indivior PLC | INDIVIOR is a registered trademark of
Indivior UK Limited | All rights reserved
This information is provided by RNS
The company news service from the London Stock Exchange
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