Indivior Inc. Introduces Mobile Application to Help Support Education, Adherence and Disease Management Needs of Patients with Opioid Dependence and Their Physicians

RICHMOND, Va., March 31, 2016 /PRNewswire/ -- Indivior Inc., announced the launch of its first mobile tool, the SUBOXONE® (buprenorphine and naloxone) Sublingual Film (CIII) Mobile Health Library™. This free app was developed to help people in treatment who are prescribed SUBOXONE Film and the physicians who treat them. It can help physicians address and engage in the management of some of the challenging aspects of this chronic condition.

Developed with input from SUBOXONE Film patients and prescribing physicians, the Mobile Health Library app offers features such as dosing reminders, symptom tracking, access to the SUBOXONE Film savings card and dose tracking. A corresponding healthcare professional version provides resources intended to engage and help support patients in their treatment, which may include daily medication, counseling and psychosocial support. In addition, the app provides doctors with important safety information, as well as access and risk evaluation and mitigation strategies (REMS) information.

"With a chronic condition like opioid dependence, it's important that patients educate themselves, have a personal treatment plan that they are comfortable and engaged with and maintain open communication with their support team," said Jarod Masci, MD, Board Certified Psychiatrist and Addiction Medicine Specialist. "A mobile app with a set of features may be a way to assist patients at any stage in their treatment journey and may also help facilitate communications between both doctors and their patients as well as family members and friends."

The SUBOXONE Film Mobile Health Library app includes:

• Information about opioid dependence and treatment with SUBOXONE Film
• Symptom and dosing trackers, with options to record notes and receive reminders
• Health Insurance Portability and Accountability Act (HIPAA) compliant lock box feature to save information such as the symptom and dosing tracker that can be shared with a physician during follow-up visits
• A discreet icon for display on users' phones and two levels of passwords to help protect patient privacy
• Important Safety Information
• Savings card access
• Formulary look up tools for HCPs

"Indivior is committed to pioneering innovative and individualized solutions to help people with opioid dependence," said Tim Baxter, Chief Medical Officer, Indivior. "The SUBOXONE Film Mobile Health Library harnesses the power and reach of mobile technology to put resources at patients' and physicians' fingertips."

The SUBOXONE Film Mobile Health Library is available as a free download for iOS, Android and Kindle Fire devices. Physicians waivered to treat opioid dependence nationwide are learning about this support resource from Indivior Clinical Liasions and are engaged in integrating its use into their practice and patients' daily lives.

About SUBOXONE Film
SUBOXONE Film, originally approved by the U.S. Food and Drug Administration (FDA) in 2010, is a prescription medicine indicated for treatment of opioid dependence and should be used as part of a complete treatment plan to include counseling and psychosocial support.[1] Treatment should be initiated under the direction of physicians qualified under the Drug Addiction Treatment Act.

About Opioid Dependence
Opioid dependence is a complex health condition with social, psychological, and biological contributing factors[2]^,[3] that may affect people from all walks of life.[4] In 2014, more than 2.4 million people suffered from pain reliever or heroin use disorder in the United States.[5] Opioid dependence is a chronic disease,[6] and relapse can occur.[7] Suppressing withdrawal symptoms and reducing cravings with medication-assisted treatment, together with counseling and behavioral therapy, may make treatment success more likely.[8]

About Indivior
Indivior is a global pharmaceutical company with a 20-year history of patient advocacy and health policy. 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.

Indication
SUBOXONE® (buprenorphine and naloxone) Sublingual Film (CIII) is a prescription medicine indicated for treatment of opioid dependence and should be used as part of a complete treatment plan to include counseling and psychosocial support.
Treatment should be initiated under the direction of physicians qualified under the Drug Addiction Treatment Act.

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.

Important Safety Information (CONTINUED)
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 SUBOXONE 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 withdrawal has been reported following the use of buprenorphine by the mother during pregnancy.

Before taking SUBOXONE Film, talk to your doctor if you are breastfeeding or plan to breastfeed your baby. SUBOXONE 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 www.IndiviorREMS.com

SUBOXONE® is a registered trademark of Indivior UK Limited

References

[1] SUBOXONE® (buprenorphine and naloxone) Sublingual Film (CIII) Prescribing Information. Richmond, VA; Indivior Inc. September 2015.
[2] Kosten TR, George TOP. The Neurobiology of Opioid Dependence: Implications for Treatment. Sci Pract Perspect. Jul 2002; 1(1): 13-20. PMCID: PMC2851054.
[3] 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.
[4] 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
[5] 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.
[6] 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.
[7] National Institute on Drug Abuse. August 2010. Drugs, Brains, and Behavior: The Science of Addiction.
[8] 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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SOURCE Indivior Inc.

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