Indivior Applauds United States Surgeon General Dr. Vivek Murthy's Report on Substance Misuse and Substance Use Disorders

RICHMOND, Va., Nov. 17, 2016 /PRNewswire/ -- Indivior PLC (LON: INDV) commends U.S. Surgeon General Dr. Vivek Murthy for the robust report released today titled, "Facing Addiction in America: The Surgeon General's Report on Alcohol, Drugs, and Health." The U.S. Surgeon General continues to demonstrate a strong commitment to this public health epidemic by recognizing innovative methods to prevent new cases of opioid addiction, identifying opioid addiction early on in individuals and ensuring access to effective opioid addiction treatments.

The U.S. Department of Health and Human Services (HHS) is also acting to address the U.S. opioid epidemic by enabling nurse practioners (NPs) and physician assistants (PAs) to immediately begin taking the 24 hours of required training to prescribe the opioid use disorder treatment, buprenorphine. Indivior applauds this action to expand access to medication-assisted treatment (MAT) in communities throughout the country.

"This report comes at a critical point in time, drawing national attention to a public health epidemic that continues to sweep the country," said Shaun Thaxter, CEO, Indivior. "We are encouraged by the proactive steps taken by the U.S. federal government to raise awareness about this chronic disease and ensure that patients have access to the treatment they need. The patient journey is a complex one and treatment requires a tailored plan based on individualized needs. Providing patients with an integrated continuum of care in mainstream medicine allows for a comprehensive treatment approach."

The Substance Abuse and Mental Health Services Administration (SAMHSA) 2015 National Survey on Drug Use and Health reports that 2.7 million Americans (aged 12 or older) had a prescription drug use disorder in the past year.¹ According to the Centers for Disease Control and Prevention (CDC), opioids, primarily prescription pain relievers and heroin, are the main drugs associated with overdose deaths.² Opioid dependence is a complex health condition with many elements to consider – biological, psychological and social. Indivior works to ensure that patients have unrestricted access to high-quality treatment services for this chronic, relapsing condition.

"Today marks an important step toward addressing this public health crisis," said Shaun Thaxter, CEO, Indivior. "Indivior has partnered with governments, policymakers, payers, advocacy groups and healthcare professionals for the past 20 years to increase education about the scientific nature of the disease and the value of medication-assisted treatment. We look forward to working with the new Congress and Administration to continue building on this important work."

About Indivior
Indivior is a global specialty pharmaceutical company with a 20-year legacy of leadership in patient advocacy, health policy and evidence-based best practice models that have revolutionized modern addiction treatment. Indivior is dedicated to transforming addiction from a global human crisis to a recognized and treated chronic disease. Building on its robust, global opioid dependence portfolio, Indivior has a strong pipeline of product candidates designed to both expand treatments in opioid dependence and address other chronic diseases of addiction – including alcohol use disorder, cocaine intoxication and schizophrenia. Headquartered in the United States in Richmond, VA, Indivior employs more than 900 individuals globally and its portfolio is available in over 40 countries worldwide. Its name is a fusion of the words individual and endeavor and its logo radiates the company's patient-centered holistic focus on expanding access to high-quality treatment services for addiction worldwide. For more information, please visit www.Indivior.com.

Important Safety Information
Do not take SUBOXONE Film if you are allergic to buprenorphine or naloxone as serious negative effects, including anaphylactic shock, have been reported.

SUBOXONE Film can be abused in a manner similar to other opioids, legal or illicit.

SUBOXONE Film contains buprenorphine, an opioid that can cause physical dependence with chronic use. Physical dependence is not the same as addiction. Your doctor can tell you more about the difference between physical dependence and drug addiction. Do not stop taking SUBOXONE Film suddenly without talking to your doctor. You could become sick with uncomfortable withdrawal symptoms because your body has become used to this medicine.

SUBOXONE Film can cause serious life-threatening breathing problems, overdose and death, particularly when taken by the intravenous (IV) route in combination with benzodiazepines or other medications that act on the nervous system (ie, sedatives, tranquilizers, or alcohol). It is extremely dangerous to take nonprescribed benzodiazepines or other medications that act on the nervous system while taking SUBOXONE Film.

You should not drink alcohol while taking SUBOXONE Film, as this can lead to loss of consciousness or even death.

Death has been reported in those who are not opioid dependent.

Your doctor may monitor liver function before and during treatment.

SUBOXONE Film is not recommended in patients with severe hepatic impairment and may not be appropriate for patients with moderate hepatic impairment.  However, SUBOXONE Film may be used with caution for maintenance treatment in patients with moderate hepatic impairment who have initiated treatment on a buprenorphine product without naloxone.

Keep SUBOXONE Film out of the sight and reach of children. Accidental or deliberate ingestion of SUBOXONE Film by a child can cause severe breathing problems and death.

Do not take SUBOXONE Film before the effects of other opioids (eg, heroin, hydrocodone, methadone, morphine, oxycodone) have subsided as you may experience withdrawal symptoms.

Injecting the SUBOXONE Film product may cause serious withdrawal symptoms such as pain, cramps, vomiting, diarrhea, anxiety, sleep problems, and cravings.

Before taking SUBOXONE Film, tell your doctor if you are pregnant or plan to become pregnant. If you are pregnant or become pregnant while taking SUBOXONE Film, alert your doctor immediately and you should report it using the contact information provided below.*

Neonatal opioid withdrawal syndrome (NOWS) is an expected and treatable outcome of prolonged use of opioids during pregnancy, whether that use is medically-authorized or illicit. Unlike opioid withdrawal syndrome in adults, NOWS may be life-threatening if not recognized and treated in the neonate. Healthcare professionals should observe newborns for signs of NOWS and manage accordingly.

Before taking SUBOXONE Film, talk to your doctor if you are breastfeeding or plan to breastfeed your baby. The active ingredients of SUBOXONE Film can pass into your breast milk. You and your doctor should consider the development and health benefits of breastfeeding along with your clinical need for SUBOXONE Film and should also consider any potential adverse effects on the breastfed child from the drug or from the underlying maternal condition.

Do not drive, operate heavy machinery, or perform any other dangerous activities until you know how SUBOXONE Film affects you. Buprenorphine in SUBOXONE Film can cause drowsiness and slow reaction times during dose-adjustment periods.

Common side effects of SUBOXONE Film include nausea, vomiting, drug withdrawal syndrome, headache, sweating, numb mouth, constipation, painful tongue, redness of the mouth, intoxication (feeling lightheaded or drunk), disturbance in attention, irregular heartbeat, decrease in sleep, blurred vision, back pain, fainting, dizziness, and sleepiness.

This is not a complete list of potential adverse events associated with SUBOXONE Film. Please see full Prescribing Information for a complete list.

*To report negative side effects associated with taking SUBOXONE Film, please call 1-877-782-6966. You are encouraged to report negative side effects of prescription drugs to the FDA. Visit www.fda.gov/medwatch or call 1-800-FDA-1088.

For more information about SUBOXONE Film, SUBOXONE^® (buprenorphine and naloxone) Sublingual Tablets (CIII), or SUBUTEX^® (buprenorphine) Sublingual Tablets (CIII), please see the respective full Prescribing Information and Medication Guide at http://www.suboxonerems.com/

REFERENCES
¹ Substance Abuse and Mental Health Services Administration. Prescription Drug Use and Misuse in the United States: Results from the 2015 National Survey on Drug Use and Health. NSDUH Data Review, September 2016. 
² Centers for Disease Control and Prevention MMWR / December 18, 2015 / Vol. 64

SOURCE Indivior PLC

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