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VIVITROL ® A Brief Clinical Overview

VIVITROL ® A Brief Clinical Overview. VIV 784A. Presentation Overview. Achieving recovery from Alcohol Dependence Combining medication with psychosocial support National consensus on the addition of medication to psychosocial support Challenges of Current Therapies Nonadherence

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VIVITROL ® A Brief Clinical Overview

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  1. VIVITROL®A Brief Clinical Overview VIV 784A

  2. Presentation Overview Achieving recovery from Alcohol Dependence Combining medication with psychosocial support National consensus on the addition of medication to psychosocial support Challenges of Current Therapies Nonadherence Relapse rates VIVITROL Mechanism of action Safety and efficacy Touchpoints℠ services

  3. Comprehensive Alcohol Dependence Treatment • Cortex • Role: • Decision making • Thinking • Reasoning • Rationalizing • Psychosocial treatments • 12-step fellowships • Faith-based support

  4. Comprehensive Alcohol Dependence Treatment Psychosocial Treatment and Medication • Limbic Region • Role: • Drive generation • VIVITROL • Cortex • Role: • Decision making • Thinking • Reasoning • Rationalizing • Psychosocial treatments • 12-step fellowships • Faith-based support

  5. Medication-Assisted TreatmentA National Consensus National Institute on AlcoholAbuse and Alcoholism National Institutes of Health National Quality Forum PLNDP National Council on Alcoholismand Drug Dependence Physicians and Lawyersfor National Drug Policy Substance Abuse & Mental Health Services Administration US Dept of Health & Human Services NationalAssociation ofDrug CourtProfessionals Institute of MedicineOf the National Academies

  6. Nonadherence Undermines Recovery1 1. Pettinati HM, et al. J Addict Dis. 2000;19:71-83.

  7. Oral Naltrexone Discontinuation Rates Pharmacy claims for NTX-PO 1,4 Guidelines recommend treatment from 3-6 months to 2 years1 The vast majority did not persist in refills for a reasonable course of treatment 1,4 Both analyses show that approximately 50% failed to refill even beyond 30 days1,4 Two additional independent studies obtained similar discontinuation rates2,3 US Department of Health and Human Services/SAMHSA study (2004)1 Kranzler et al., Addiction 20084 • 1. Harris KM, et al. Psychiatr Serv. 2004;55:221. • 2. Hermos JA, et al. Alcohol Clin Exp Res. 2004;28:1229-1235. • 3. Un H, Addiction Health Services Research Conference, Boston 2008 • 4. Kranzler HR, et al. Addiction. 2008:103(11):1801-1808.

  8. Medications for Alcohol Dependence Antabuse®(disulfiram)1 ReVia®(naltrexone)2 Campral® (acamprosate)3 VIVITROL®(naltrexone for extended-release injectable suspension)4 30 tabs/month*(1 tab/day) 180 tabs/month*(2 tabs, 3x/day) 30 tabs/month*(1 tab/day) 1/month 2006 1951 1994 2004 1. Antabuse full Prescribing Information. Odyssey Pharmaceuticals, Inc. 2. ReVia full Prescribing Information. Duramed Pharmaceuticals, Inc. 3.Campral full Prescribing Information. Merck Santé s.a.s. 4.VIVITROLFull Prescribing Information. Alkermes, Inc. *Based on a month with 30 days.

  9. What is VIVITROL? VIVITROL is NOT1: Addictive Aversive (e.g. disulfiram) Euphorigenic (i.e. pleasure producing) VIVITROL is1: An opioid blocker (i.e. antagonist) Extended-release (30 days) Compatible with psychosocial treatments, antidepressants and Alcoholics Anonymous2 Administered by a healthcare professional (use can be monitored) VIVITROL Full Prescribing Information. Alkermes, Inc. Gromov, I., et al. AMERSA, Washington, DC, November 8, 2007.

  10. VIVITROL Indication VIVITROL is indicated for the treatment of alcohol dependence in patients who are able to abstain from alcohol in an outpatient setting prior to initiation of treatment with VIVITROL. Patients should not be actively drinking at the time of initial VIVITROL administration. Treatment with VIVITROL should be part of a comprehensive management program that includes psychosocial support. VIVITROL[full prescribing information]. Cambridge, MA: Alkermes, Inc; May 2009.

  11. Important Safety Information VIVITROL is contraindicated in patients receiving opioid analgesics or with current physiologic opioid dependence,patients in acute opiate withdrawal, any individual who has failed the naloxone challenge test or has a positive urine screen for opioids, or in patients who have previously exhibited hypersensitivity to naltrexone, PLG, carboxymethylcellulose or any other components of the diluent. VIVITROL patients must be opioid free for a minimum of 7-10 days before treatment. Attempts to overcome opioid blockade due to VIVITROL may result in a fatal overdose. In prior opioid users, use of opioids after discontinuing VIVITROL may result in a fatal overdose because patients may be more sensitive to lower doses of opioids. VIVITROL[full prescribing information]. Cambridge, MA: Alkermes, Inc; May 2009.

  12. Important Safety Information In an emergency situation in patients receiving VIVITROL, suggestions for pain management include regional analgesia or use of non-opioid analgesics. If opioid therapy is required as part of anesthesia or analgesia, such patients should be continuously monitored, in an anesthesia care setting, by persons not involved in the conduct of the surgical or diagnostic procedure. The opioid therapy must be provided by individuals specifically trained in the use of anesthetic drugs and the management of the respiratory effects of potent opioids, specifically the establishment and maintenance of a patent airway and assisted ventilation. Irrespective of the drug chosen to reverse the VIVITROL blockade, the patient should be monitored closely by appropriately trained personnel in a setting equipped and staffed for cardiopulmonary resuscitation. VIVITROL[full prescribing information]. Cambridge, MA: Alkermes, Inc; May 2009.

  13. Important Safety Information Naltrexone has the capacity to cause hepatocellular injury when given in excessive doses. Naltrexone is contraindicated in acute hepatitis or liver failure, and its use in patients with active liver disease must be carefully considered in light of its hepatotoxic effects. The margin of separation between the apparently safe dose of naltrexone and the dose causing hepatic injury appears to be only five-fold or less. VIVITROL does not appear to be a hepatotoxin at the recommended doses. Patients should be warned of the risk of hepatic injury and advised to seek medical attention if they experience symptoms of acute hepatitis. Use of VIVITROL should be discontinued in the event of symptoms and/or signs of acute hepatitis. VIVITROL[full prescribing information]. Cambridge, MA: Alkermes, Inc; May 2009.

  14. Important Safety Information VIVITROL [full prescribing information]. Cambridge, MA: Alkermes, Inc; 2009. VIVITROL[full prescribing information]. Cambridge, MA: Alkermes, Inc; May 2009. VIVITROL is administered as an intramuscular gluteal injection. Inadvertent subcutaneous injection of VIVITROL may increase the likelihood of severe injection site reactions. VIVITROL must be injected using the customized needle provided in the carton. Because needle length may not be adequate due to body habitus, each patient should be assessed prior to each injection to assure that needle length is adequate for intramuscular administration. VIVITROL injection site reactions may be followed by pain, tenderness, induration, swelling, erythema, bruising or pruritus; however, in some cases injection site reactions may be very severe. Injection site reactions not improving may require prompt medical attention, including in some cases surgical intervention.

  15. Important Safety Information VIVITROL [full prescribing information]. Cambridge, MA: Alkermes, Inc; 2009. VIVITROL[full prescribing information]. Cambridge, MA: Alkermes, Inc; May 2009. Consider the diagnosis of eosinophilic pneumonia if patients develop progressive dyspnea and hypoxemia. Alcohol dependent patients, including those taking VIVITROL, should be monitored for the development of depression or suicidal thoughts. Caution is recommended in administering VIVITROL to patients with moderate to severe renal impairment. The most common adverse events associated with VIVITROL in clinical trials were nausea, vomiting, headache, dizziness, asthenic conditions and injection site reactions.

  16. Opioid Receptors and Alcohol Dependence 1.Gianoulakis C. Alcohol Health Res World. 1998;22:202-210. 2. Woodward JJ. Principles of Addiction Medicine. 3rd ed. 2003:101-118.

  17. VIVITROL: A Targeted Approach The mechanism by which VIVITROL exerts its effects in alcohol-dependent patients is not entirely understood. 1. VIVITROL full Prescribing Information. Alkermes, Inc. 2. Oswald LM, et al. PhysiolBehav. 2004;81:339-358. 3.Kenna GA, et al. Am J Health Syst Pharm. 2004;61:2272-2279. 4.Gianoulakis C. Alcohol Health Res World. 1998;22:202-210.

  18. VIVITROL Microspheres1,2 Elimination: polymer eventually metabolized and eliminated as CO2 and H2O Hydration Diffusion Erosion 1. Dean RL. Front Biosci. 2005;10:643-655. 2. Data on file. Alkermes, Inc.

  19. VIVITROL Provides aSustained-Release of Medication Mean steady-state naltrexone concentration following monthly VIVITROL compared to daily oral dosing1 VIVITROL IM Injection Oral naltrexone 50 mg 1. Dunbar JL, et al. Alcohol Clin Exp Res. 2006;30:480-490.

  20. Pharmacokinetics Reduced first-pass hepatic metabolism vs oral naltrexone1 The cytochrome P450 system is not involved in naltrexone metabolism1 No clinical drug interaction studies have been performed Lower total monthly dose: 380mg of VIVITROL vs 1500mg of oral naltrexone1 Total area-under-the-curve of VIVITROL is approximately 4-times that with oral naltrexone2 • VIVITROL Full Prescribing Information. Alkermes, Inc. • Dunbar, JL. Et al. Alcohol and Clin Exp Res. 2006;30(3):480-490

  21. VIVITROL Eliminates DailyAdherence Decisions1 VIVITROL utilizes a delivery system that Provides a month of medication in a single dose Adherence to any treatment program is essential for successful outcomes Administration by a healthcare provider ensuresthat the patient receives the medication as directed “…addressing patient adherence systematically will maximize the effectiveness of these medications.”2 –Updated NIAAA Clinician’s Guide 1. Dean RL. Front Biosci. 2005;10:643-655. 2. NIAAA. 2007. NIH publication 07-3769.

  22. Phase III Safety & Efficacy TrialRandomized, double-blind, placebo-controlled study1-3 899 assessed for eligibility 624 DSM-IV alcohol-dependent patients randomized Received 24-weeks treatment including 12 sessions of standardized counseling Multicenter: 24 outpatient sites Placebo Microspheres n=209 XR-NTX 190 mg n=210 VIVITROL n=205 134 received all 6 injections 137 received all 6 injections 130 received all 6 injections 64% 65% 63% 128 completed trial 126 completed trial 124 completed trial 61% 60% 60% • No oral naltrexone lead-in 1.Garbutt JC, et al. JAMA.2005;293:1617-1625. 2.Volpicelli JR, et al. Combining Medication and Psychosocial Treatments for Addictions: The BRENDA Approach. 2001. 3. Data on file. Alkermes, Inc.

  23. VIVITROL Provided Rapid Results When VIVITROL was added to counseling*… Reductions were rapid1 • Post hoc analysis of a randomized, double-blind, placebo-controlled study. Patients had ≥2 heavy drinking episodes/week during the month prior to screening. Inclusion did not require detoxification, abstinence or intent to abstain from alcohol1 • VIVITROL is indicated for the treatment of alcohol dependence in patients who are able to abstain from alcohol in an outpatient setting prior to initiation of treatment with VIVITROL. Patients should not be actively drinking at the time of initial VIVITROL administration2 • Approval of VIVITROL was based on a subset of patients who were able to abstain for 7 days prior to treatment initiation1 Counseling* with PLACEBO (n=209) Counseling* with VIVITROL (n=205) *The counseling used with all subjects was BRENDA, a low-intensity intervention designed to facilitate direct feedback of alcohol-related consequences. BRENDA consists of biopsychosocial assessment, reporting the assessment to the patient, an empathetic approach, identified and stated patient needs, direct advice regarding drinking behavior, and assessment of treatment adherence. • Ciraulo D et al. J Clin Psychiatry. 2008;69(2):190-195. • VIVITROL Full Prescribing Information. Cambridge, MA. Alkermes, Inc.; 2008.

  24. VIVITROL Significantly Reduces Drinking Days1,2 Reductions were substantial1† Counseling with VIVITROL (n=28) Counseling with PLACEBO (n=28) Baseline (n=56) • According to the SAMHSA/CSAT, 4 days is the US norm (median duration) for detoxification2 • Approval of VIVITROL was based on a subset of patients who were able to abstain for 7 days prior to treatment initiation1 • † These results are from a post hoc subgroup analysis of a 6-month, multicenter, double-blind, placebo-controlled clinical trial of alcohol dependent patients. This subset analysis evaluated patients who were abstinent for 4 or more days prior to treatment initiation1 • O’Malley SS et al. J ClinPsychopharmacol. 2007;27(5):507-512. • Drug and Alcohol Services Information System. The DASIS report: discharges from detoxification: 2000. http://oas.samhsa.gov/2K4/detoxDischarges/detoxDischarges.pdf. Published July 9, 2004. Accessed January 23, 2008. .

  25. VIVITROL Sustained Abstinence1 VIVITROL maintained 6-month abstinence Nearly three times as many patients remained abstinent 32% 11% VIVITROL prolonged initial abstinence Counseling with PLACEBO (n=28) Counseling with VIVITROL (n=28) • Results are from a post hoc subgroup analysis of a 6-month multicenter, double-blind, • placebo controlled clinical trial of alcohol dependents who were abstinent for 4 or more days • prior to treatment initiation. • The approval of VIVITROL was based on a subset of patients who were able to • abstain for 7 days prior to treatment initiation. 1. O’Malley SS, et al. J ClinPsychopharm. 2007;27:507-512.

  26. VIVITROL Sustained Reduction in Heavy Drinking Among patients receiving VIVITROL or placebo in the 6-month trial Placebo ( n=209) Patients continuing on VIVITROL (n=115) Patients switching from placebo to VIVITROL (n=60) VIVITROL (n=205) Data on file. Alkermes, Inc.

  27. VIVITROL Reduced Holiday Drinking1 Median % Drinking Days “The public health significance of the findings by Lapham et al. in this issue is huge.2” --David Rosenbloom, Ph.D. Boston University School of Public Health (2009) n=27 • Results are from a post hoc subgroup analysis of a 6-month multicenter, double-blind, • placebo controlled clinical trial of alcohol dependents who were abstinent for 4 or more days • prior to treatment initiation. • The approval of VIVITROL was based on a subset of patients who were able to • abstain for 7 days prior to treatment initiation. • Lapham. J Subst Abuse Treat. 2009;36:1. • Rosenbloom DL. J Subst Abuse Treat. 2009;36(1):7.

  28. Rapid results Substantial reduction in drinking days Prolonged initial abstinence Sustained continuous abstinence through the 6-month study Sustained reduction in heavy drinking days through 18 months Substantial reduction in holiday drinking Summary of Efficacy Results1,2 In clients who were abstinent during the week before treatment initiation, VIVITROL and counseling, as compared to placebo and counseling, provided: 1. O’Malley SS, et al. J ClinPsychopharmacol. 2007;27:507-512. 2. VIVITROL Full Prescribing Information. Alkermes, Inc.

  29. Safety Profile During clinical trials: Treatment with extended-release naltrexone was generally well tolerated Safety profile is based on more than 900 patients Adverse events in the majority of patients were mild or moderate Discontinuation rates due to adverse events: 9% in patients treated with VIVITROL 7% in patients treated with placebo The safety profile of patients treated with VIVITROL concomitantly with antidepressants was similar to that of patients taking VIVITROL without antidepressants1 No significant increase in mean AST or ALT levels2 • VIVITROL Full Prescribing Information. Alkermes, Inc. • Garbutt JC, et al. JAMA.2005;293:1617-1625.

  30. Most Common Adverse Events Occurring in >10% of patients *Injection site reaction (ISR) included tenderness, induration, pain, and pruritus. The dropout rate due to ISR was 3%. VIVITROL Full Prescribing Information. Alkermes, Inc.

  31. Serious Adverse Events In clinical trials, serious adverse events occurred at a rate similar to patients receiving placebo injections1 5.4% on VIVITROL vs 7.2% on placebo Most common serious adverse event (SAE) was inpatient hospitalization for detoxification Other SAEs seen on VIVITROL2 2 cases of pneumonia (one confirmed case of eosinophilic) 1 case of injection site induration requiring excision 1.Garbutt JC, et al. JAMA.2005;293:1617-1625. 2. VIVITROL Full Prescribing Information. Alkermes, Inc.

  32. Emergency Pain Management VIVITROL antagonizes the effects of opioid-containing medications.Patients receiving VIVITROL may not benefit from opioid-containing medications. • Patients should be advised to carry a patient alert card that informs medical personnel they are taking VIVITROL • A suggested plan for pain management is: • Regional analgesia • Use of non-opioid analgesics • In an emergency situation requiring opioid analgesia, the amount of opioid required may be greater than usual and the resulting respiratory depression may be deeper and more prolonged • Such patients should be continuously monitored in an anesthesia care setting by persons not involved in the conduct of the surgical or diagnostic procedure • The opioid therapy must be provided by individuals specifically trained in the use of anesthetic drugs and the management of the respiratory effects of potent opioids, specifically the establishment and maintenance of a patent airway and assisted ventilation • A rapidly acting opioid analgesic that minimizes the duration of respiratory depression is preferred • Patients should be closely monitored by trained personnel in a setting equipped for cardiopulmonary resuscitation.

  33. Dosage and Administration VIVITROL is given as an intramuscular (IM) gluteal injection every 4 weeks or once a month VIVITROL should not be given subcutaneously or in the adipose layer VIVITROL must not be administered intravenously VIVITROL should be administeredby a healthcare professional, into alternating buttocks each month VIVITROL should be injected into the upper outer quadrant of the buttock, deep into the muscle-not the adipose. Epidermis Dermis Adipose Muscle VIVITROL Full Prescribing Information. Alkermes, Inc.

  34. Introducing… Connecting people with care in recovery. A free service for patients and treatment providers designed to: • Promote long-term recovery • Improve access to treatment • Support continuity of care

  35. Specializing in supporting continuity of therapy for VIVITROL patients transitioning between settings of care Offering patients a free start on the path to recovery Connecting customers to reimbursement and distribution services An integrated network of providers supporting VIVITROL assisted recovery Enhancing knowledge of VIVITROL assisted recovery and offering tools to aid in treatment Providing confidential, supportive help for patients during recovery 1-800-VIVITROL (1-800-848-4876) www.vivitrol.com

  36. VIVITROL Carton Components

  37. APPENDIX

  38. Alcohol Dependence: An Ancient Problem After the flood, Noah plants a vineyard, makes wine and gets drunk. (Genesis 9:21) “Who hath woe? Who hath sorrow? Who is always fighting?Who is always complaining? Who hath wounds without cause?Who has bloodshot eyes? They who tarry long at the wine; when it sparkles in the cup. Don't let the smooth taste deceive you. For in the end it bites like a poisonous serpent. And you will say, ‘They hit me, but I didn't feel it.’ Your eyes will see strange visions and you will say strange thoughts. Yet when you awaken, you seek it yet again.” Proverbs 23:29 (~1,000 BC)

  39. National Institute on AlcoholAbuse and Alcoholism National Institutes of Health Medication-Assisted Treatment:A National Consensus “Consider adding medication wheneveryou are treating someone with active alcohol dependence.” National Institute on Alcohol Abuse and Alcoholism. Helping Patients Who Drink Too Much: A Clinician’s Guide. Available at: http://pubs.niaaa.nih.gov/publications/Practitioner/CliniciansGuide2005/clinicians_guide.htm.May 2007 reprint. Accessed May 5, 2008.

  40. Medication-Assisted Treatment:A National Consensus “Patient nonadherence is a common problem with all types of oral medications. In addition, people with substance use disorders experience fluctuations in their motivation for abstinence, further affecting their compliance … With injectable naltrexone, one intramuscular injection is effective for 4 weeks, reducing opportunities for patients to cease their medication.” U.S. Department of Health and Human Services, Substance Abuse and Mental Health Services Administration, Center for Substance Abuse Treatment Advisory (Spring 2007) http://kap.samhsa.gov/products/manuals/advisory/index.htm

  41. Medication-Assisted Treatment:A National Consensus Substance Abuse & Mental HealthServices Administration U.S. Department of Health and Human Services “A combination of medication and behavioral therapies ismost successful.” Substance Abuse & Mental Health Services Administration, Division of Pharmacologic Therapies. Medication-Assisted Treatment for Substance Use Disorders. Available at: http://www.dpt.samhsa.gov. Accessed May 5, 2008.

  42. National Quality Forum Medication-Assisted Treatment:A National Consensus “Pharmacotherapy should be … available to all adult patients diagnosed with alcohol dependence … [and] should be provided in addition to … psychosocial treatment/support.” National Quality Forum. 2007. National Voluntary Consensus Standards for the Treatment of Substance Use Conditions: Evidence-Based Treatment Practices. Available at: http://www.qualityforum.org/pdf/reports/sud/sudexesummary.pdf.Accessed May 5, 2008.

  43. Medication-Assisted Treatment:A National Consensus Institute of Medicineof the National Academies “[There is] a spectrum of evidence-based pharmacologic & psychosocial treatments … Naltrexone [shows] efficacy in treating [alcohol dependence].” Institute of Medicine of the National Academies. Improving the Quality of Health Care for Mental and Substance-Use Conditions: Quality Chasm Series. Committee on Crossing the Quality Chasm: Adaptation to Mental Health and Addictive Disorders. Executive Summary. 2006. Available at: http://www.iom.edu/CMS/3809/19405/30836.aspx. Accessed May 5, 2008.

  44. National Council on Alcoholismand Drug Dependence Medication-Assisted Treatment:A National Consensus “Integrate biological, psychosocial,and pharmacological approaches.All are helpful and necessary.” The National Council on Alcoholism and Drug Dependence. Interviews with the Experts: Robert Morse, MD on the Use of Pharmacology in Addiction Treatment. http://www.ncadd.org/facts/morse.html. Accessed May 5, 2008.

  45. Alcoholics Anonymous published a booklet for AA members (1984) Booklet supports appropriately prescribed medications Booklet is being updated to address new medications Alcoholics Anonymous(AA) and Use of Medication Alcoholics Anonymous World Service, Inc. The AA Member – Medications and Other Drugs. 1984.

  46. Typical Clinical Team Roles Counselor (psychosocial treatment provider) Provides psychosocial treatment Monitors response to medication Communicates patient status with treatment team Physician (prescriber/injector) Assesses appropriateness of medication for patient Monitors medical response to medication Communicates patient status with treatment team Nurse (injector) Administers medication Monitors medical response to medication Communicates patient status with treatment team Provides psychosocial treatment Assesses appropriateness of medication for patient Administers medication

  47. Development of VIVITROL Problem of nonadherence was well understood by 19751 NIAAA and NIDA awarded grants that led to development of Medisorb®* technology VIVITROL uses the Medisorb extended-release properties, first introduced in Risperdal®Consta®† * Medisorb is a registered trademark of Alkermes, Inc. † Risperdal and Consta are registered trademarks of Janssen Pharmaceutica. 1. NIDA Monograph. Narcotic Antagonists: The Search for Long-Acting Preparations.

  48. Pharmacokinetics Minimal accumulation (<15%) of naltrexone or 6-naltrexol upon repeat administration of VIVITROL Elimination Primarily via urine for naltrexone and its metabolites Minimal excretion of unchanged naltrexone Half-life 5 to 10 days (dependent on erosion of polymer) VIVITROL Full Prescribing Information. Alkermes, Inc.

  49. Among patients who were abstinent for 7 days prior to treatment initiation VIVITROL Prolongs Abstinence1,2 VIVITROL maintained 6-month abstinence More than twice as many patients remained abstinent 41% 17% VIVITROL prolonged initial abstinence (n=17) 1. Garbutt JC, et al. JAMA. 2005;293:1617-1625. 2. Data on file. Alkermes, Inc. .

  50. Subjects With Nausea by Month Mild in the majorityof reports Occurred in the first month in the majority of cases Median duration of a few days Trial dropout rate due to nausea was 2% in the VIVITROL group Data on file. Alkermes, Inc.

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