Indivior Presents Late-Breaking, Real-World Data Revealing Less than Half of Patients with Opioid Use Disorder Receive Medication-Assisted Treatment

RICHMOND, Va., April 15, 2016 /PRNewswire/ -- Indivior Inc., a subsidiary of Indivior PLC (LON: INDV), presented new research from an analysis of more than 100,000 commercially insured patients indicating underutilization of treatment methods for patients with opioid use disorder (OUD), suggesting a growing need for improved access to medication-assisted treatment (MAT). Findings were presented in a poster session today at the American Society of Addiction Medicine 47^th Annual Conference in Baltimore.

In a retrospective observational study, researchers analyzed administrative claims from the Truven Health MarketScan^® Commercial Database among 103,768 commercially insured patients with OUD between 2008 and 2014, with a mean duration of follow up of 702 days. As one of the largest studies of this kind, researchers found that post-diagnosis, nearly one-third (31.6 percent) of patients were receiving no opioid dependence treatment. Further, less than half (42.8 percent) of patients were prescribed MAT, with buprenorphine/naloxone being the most commonly prescribed (34.4 percent of the overall OUD patients).ⁱ

"The study revealed that almost one-quarter (24.3 percent) of patients diagnosed with OUD received a recommended method of treatment, both MAT and psychosocial care, reaffirming my observations in clinical practice that treatment access continues to be an issue,"ⁱⁱ said Dr. Bernd Wollschlaeger, MD, FAAFP, FASAM, Aventura Family Health Center. "I'm optimistic that with continued research and community support, we can work together to help ensure MAT is accessible to appropriate patients, when and where they need it, and psychosocial care is provided to help support them in their journey." 

A majority of patients received OUD-related care in the outpatient setting. Of these, almost one-quarter of patients (22.9 percent) visited a psychiatrist and almost one-third (31.1 percent) visited a primary care physician. The researchers also found that the pre-treatment study population had higher rates of pain-related conditions (chronic pain: 48.6 percent, narcotic pain medications: 53.1 percent) and psychiatric comorbidities (depressive disorders: 24.0 percent, prescriptions of antidepressants: 42.7 percent). The researchers recommend additional studies to better understand factors impacting the way patients receive and access treatment. Identifying these factors may help strengthen future community-based programs to address existing treatment gaps in clinical settings.

"Indivior is pleased to share these findings at the ASAM Annual Conference, as these insights bring us one step further in evolving the way we understand, interpret and respond to the barriers patients face in their journey," said Dr. Tim Baxter, Chief Medical Officer, Indivior. "We look forward to expanding upon this research and sharing additional data at future congresses so that we can work with the medical community to find new ways to better connect patients to treatment."

About the Study Design
The intent of the study was to illustrate a comprehensive, real-world view of the characteristics, clinical burden and treatment received across men (57 percent) and women (43 percent) of diverse ages, with a mean age of 36 years. The study time period (index date) was defined as the earliest date with a diagnosis of opioid dependence between January 1, 2008 and March 31, 2014. Patient demographics were measured on the index date. A six month pre-index period was used to measure baseline patient clinical characteristics, including the Deyo-Charlson Comorbidity Index, comorbid conditions and concomitant medications. Researchers also evaluated the type of OUD treatment received (i.e., detoxification, psychosocial treatment, and MAT) from each patient's healthcare claims.

About Opioid Dependence
Opioid dependence is a complex health condition with social, psychological, and biological contributing factors^iii,iv that can affect anyone.^v,vi In 2014, more than 2.4 million people suffered from pain reliever or heroin use disorder in the United States.^vii Opioid dependence is a chronic disease,^viii and relapse can occur.^ix Suppressing withdrawal symptoms and reducing cravings with medication-assisted treatment, together with counseling and behavioral therapy, may make treatment success more likely.^x

About Indivior
Indivior is a global specialty pharmaceutical company with a 20-year legacy in patient advocacy, health policy and evidence-based best practice models that have helped to advance modern addiction treatment. 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 opioid dependence portfolio including SUBOXONE® (buprenorphine and naloxone) Sublingual Film (CIII), SUBOXONE® (buprenorphine and naloxone) Sublingual Tablet, and SUBUTEX® (buprenorphine) Sublingual Tablet, Indivior has a pipeline of product candidates designed to both expand on its heritage in this category and address other chronic diseases of addiction – including opiate overdose, alcohol use disorders and cocaine intoxication. It also is pursuing novel product candidates in related mental health disorders such as schizophrenia. Headquartered in the United States in Richmond, Va., Indivior employs more than 700 individuals globally and its portfolio is available in over 40 countries worldwide. Visit www.Indivior.com to learn more.

Forward-Looking Statements
This press release contains forward-looking statements. We may, in some cases, use terms such as "predicts," "believes," "potential," "proposed," "continue," "estimates," "anticipates," "expects," "plans," "intends," "may," "could," "might," "will," "should" or other words that convey uncertainty of future events or outcomes to identify these forward-looking statements. Forward-looking statements include statements regarding our intentions, beliefs, projections, outlook, analyses or current expectations.

Various factors may cause differences between Indivior's expectations and actual results, including: factors affecting sales of SUBOXONE Tablet, SUBOXONE Film, SUBUTEX Tablet and any future 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 the SUBOXONE Film patent litigation relating to the two 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.

Any forward-looking statements that we make in this press release speak only as of the date of this press release. We assume no obligation to update our forward-looking statements whether as a result of new information, future events or otherwise, after the date of this press release.

References

ⁱ Wollschlaeger, BA, Montejano LB, Willson TM, Ronquest NA, Nadipelli VR. Half of Commercially Insured Patients with Opioid Use Disorder Receive Medication-Assisted Treatment. 2016. Presented at the American Society of Addiction Medicine 47th Annual Conference.
ⁱⁱ Kleber, H. D., Weiss, R. D., Anton, R. F., George, T. P., Greenfield, S. F., Kosten, T. R., O'Brien, C. P., … Connery, H. S. (2007). Treatment of patients with substance use disorders: Second edition. The American Journal of Psychiatry, 164(4), 3-123.
ⁱⁱⁱ Kosten TR, George TOP. The Neurobiology of Opioid Dependence: Implications for Treatment. Sci Pract Perspect. Jul 2002; 1(1): 13-20. PMCID: PMC2851054.
^iv World Health Organization. United Nations Office on Drugs and Crime, Joint United Nations Program on HIV/AIDS. Position paper. Substitution maintenance therapy in the management of opioid dependence and HIV/AIDS prevention. Geneva, Switzerland: World Health Organization; 2004.
^v Substance Abuse and Mental Health Services Administration. Characteristics of substance abuse treatment admissions reporting primary abuse of prescription painkillers: 1998 and 2008. The TEDS Report. Sept 23, 2010:1-6
^vi Wu LT, Woody GE, Yang C, Blazer DG. How do prescription opioid users differ from users of heroin or other drugs in psychopathology: Results from the national epidemiologic survey on alcohol and related conditions. J Addict Med. 2011;5(1):28–35. doi: 10.1097/ADM.0b013e3181e0364e.
^vii U.S. Department of Health and Human Services: Substance Abuse and Mental Health Services Administration Center for Behavioral Health Statistics and Quality. Results from the 2014 National Survey on Drug Use and Health: Summary of National Findings. Sep 2015. http://www.mentalhealth.va.gov/providers/sud/docs/english_buprenorphine_facts.pdf. Accessed April 26, 2014.
^viii US DEPARTMENT OF HEALTH AND HUMAN SERVICES: Substance Abuse and Mental Health Services Administration Center for Substance Abuse Treatment. The facts about BUPRENORPHINE for the treatment of opioid dependence 2009. Available at: http://www.mentalhealth.va.gov/providers/sud/docs/english_buprenorphine_facts.pdf. Accessed April 26, 2014.
^ix National Institute on Drug Abuse. August 2010. Drugs, Brains, and Behavior: The Science of Addiction.
^x Parran et al. Drug Alcohol Depend. 2010 January 1;106(1): 56-60. Doi:10.1016/j.drugalcdep.2009.07.013.

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