Patient-Reported Outcomes Data on SUBLOCADE™ (Buprenorphine Extended-Release) Injection to be Presented as Late-Breaker at American Society of Addiction Medicine (ASAM) 49th Annual Conference

Patients in the de novo cohort demonstrated sustained improvements from baseline in patient-reported outcomes, including mental health, drug use, employment and family/social status when treated with SUBLOCADE during the study¹. Patients in the roll-over SUBLOCADE cohort reported sustained or improved outcomes during the additional six months of treatment in this study, including statistically significant improvements from baseline in medical status, drug use, family/social status and psychiatric status¹. Patient-reported outcomes in the roll-over placebo cohort remained stable¹. Changes in patient-reported outcomes in the de novo cohort mirrored those in the roll-over SUBLOCADE cohort, where improvements in the first six months of treatment (in the RB-US-13-0001 study) were followed by sustained outcomes with an additional six months of treatment (in the present study)^1,2,3.

More information about this study can be found online on the ASAM website here.

About SUBLOCADE^™
SUBLOCADE is approved by the U.S. Food and Drug Administration (FDA) for the treatment of moderate to severe OUD in adult patients who have initiated treatment with a transmucosal buprenorphine-containing product, followed by dose adjustment for a minimum of seven days⁴. It should be administered only by healthcare providers and should be used as part of a complete treatment program that includes counseling and psychosocial support⁴. The overall safety profile for SUBLOCADE, given by a healthcare provider in clinical trials, was consistent with the known safety profile of transmucosal buprenorphine, except for injection site reactions⁴. Common adverse reactions associated with buprenorphine included constipation, nausea, vomiting, abnormal liver enzymes, headache, sedation and somnolence⁴. Injection site reactions were reported in 16.5 percent of patients in Phase 3 studies⁴. Most of the injection site adverse reactions (ADRs) were of mild to moderate severity⁴. None of the injection site reactions were serious and one led to study treatment discontinuation⁴.

SUBLOCADE has a BOXED WARNING and is available through restricted distribution under the SUBLOCADE Risk Evaluation and Mitigation Strategy (REMS) Program⁴. 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 patient⁴. Moreover, certified healthcare settings and pharmacies must not distribute, transfer, loan or sell SUBLOCADE⁴.

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^® 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.

For further product information, see full Prescribing Information including BOXED WARNING and Medication Guide at www.SUBLOCADE.com.

About Opioid Use Disorder (OUD)

Opioid use disorder (OUD), sometimes referred to as opioid addiction, is a chronic disease⁴. 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 condition⁵."   

Based on 2016 data from the National Survey on Drug Use and Health report, approximately 11.8 million Americans (age 12+ years) engaged in misuse of opioids in the past year⁶. From 1999 to 2016, the rate of deadly prescription opioid overdoses increased five-fold⁷. In 2016, an average of 115 people died of opioid overdose each day in the United States⁸. In addition, in 2016, 935,000 adults used heroin and approximately 625,000 adults had a heroin use disorder⁶. In 2015, opioids accounted for 70 percent of the disease burden associated with drug use disorders worldwide⁹.

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 for all patients around the world to have access to evidence-based treatment for the chronic conditions and co-occurring disorders of addiction. The name is the fusion of the words individual and endeavor, 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 1,000 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 2018 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. Ling, W., Nadipelli, V. R., Solem, C. T., Ronquest, N. A., Yeh, Y., Heidbreder, C., Learned, S., Mehra, V. (2018, April). Impact of RBP-6000 (Once-Monthly Depot Buprenorphine) on Patient-Reported Outcomes: A Long-Term Study. American Society of Addiction Medicine 49^th Annual Conference. San Diego, CA.
2. Learned, S., Haight, B., Laffont, C., Li, D., Fudala, P., Heidbreder, C. (2017, June). RBP-6000 Buprenorphine Monthly Depot Demonstrates Efficacy, Safety and Exposure-Response Relationship in Opioid Use Disorder. College on Problems of Drug Dependence 79^th Annual Scientific Meeting. Montreal, Canada.
3. Nadipelli, V.R., Solem, C.T., Ronquest, N.A., Yeh, Y., Heidbreder, C., Learned, S., Mehra, V. (2017, November). Impact of RBP-6000 on Patient-Reported Outcomes in Patients with Opioid Use Disorder: Results of a Randomized, Placebo-Controlled, Phase 3 Study. The 41^st Association of Medical Education and Research in Substance Abuse Annual National Conference. Washington, D.C.
4. SUBLOCADE™ [Prescribing Information]. Indivior Inc., North Chesterfield, VA. March 2018.
5. American Psychiatric Association (2013). Diagnostic and Statistical Manual of Mental Disorders (5th ed.). Arlington, VA: American Psychiatric Publishing.
6. 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/sites/default/files/NSDUH-FFR1-2016/NSDUH-FFR1-2016.htm. Accessed March 23, 2018.
7. Centers for Disease Control and Prevention. (2017). Prescription Opioid Overdose Data. Retrieved from: https://www.cdc.gov/drugoverdose/data/overdose.html. Accessed March 23, 2018.
8. Centers for Disease Control and Prevention. Understanding the Epidemic. Retrieved from: https://www.cdc.gov/drugoverdose/epidemic/index.html. Accessed March 23, 2018.
9. United Nations Office on Drugs and Crime (2017). 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). Vienna, Austria: United Nations.

SUBLOCADE is a trademark of Indivior UK Limited.

© Indivior PLC | INDIVIOR is a registered trademark of Indivior UK Limited | All rights reserved

For further product information, see full Prescribing Information including BOXED WARNING and Medication Guide at www.SUBLOCADE.com.

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SOURCE Indivior PLC