1) The document discusses the issues of opioid and alcohol dependence in the United States, noting that opioid dependence has reached epidemic levels and alcohol dependence affects many Americans. 2) It describes the drug Vivitrol (naltrexone) which is a once-monthly injection used to treat these dependencies. Vivitrol blocks the rewarding effects of opioids and alcohol to help prevent relapse when used along with counseling. 3) Studies show patients receiving Vivitrol had greater reductions in opioid cravings and drinking days than those receiving placebo, demonstrating Vivitrol's ability to help support recovery from alcohol and opioid dependence when used as part of a treatment program.

1. PARTNERING TOGETHER TO STAY ON THE PATH TO
RECOVERYFROMALCOHOLOROPIOIDDEPENDENCE
I’M READY TO MOVE
FORWARD“I’
“I’
”

2. opioid Dependence Has reached Epidemic levels
Alcohol dependence is one of the most prevalent
mental disorders in the U.S.
1 out of every 4 families has alcoholism in the family [Silverstein 1990]
Approximately 76 million US adults grew up with, married, or had a blood
relative who is an alcoholic or problem drinker [Schoenborn 1991]
2000
1800
1600
1400
1200
1000
800
600
400
200
0
2002
NumberofOpioid-DependentAmericansinThousands
Year
2003 2004 2005 2006 2007 2008 2009 2010 2011
Opioid Dependence in the U.S. Has Increased Over the Past Decade
>50%
INCREASE
FROM 2002-2011
Unintentional deaths due to opioid overdose are increasing in the U.S.
14,000
12,000
10,000
8,000
6,000
4,000
2,000
0
20032000 20042001 20021999 2005 2006 2007
NumberofDeaths
Year
Opioid analgesic
Heroin
FPO
7,900,000
Nearly 8 million Americans 18 and older were dependent on alcohol in 2010
Alcohol Dependence Affects Many Americans

3. two regions of the Brain are Affected by Dependence
Medication targets
the limbic region3-6
The role of the
limbic region is:
- Basic drives or urges
- Rewards
- Pleasure
Addressing the psychological, social and behavioral effects
of addiction through counseling is very important2
Treating the psychological aspects of addiction can:
Address motivation to change
Provide incentives for abstinence
Help build recovery skills
replace drugs with rewarding activities
recovery is a life-long Process
Comprehensive treatment for dependence should address both
psychosocial and biological components
Counseling
targets the cortex3,4
The role of the cortex is:
- Decision making
- Thinking
- Reasoning
- Learning
Addiction is a chronic, relapsing brain disease and as with other chronic diseases:
[NIDA Principles]
Successful treatment usually requires continual evaluation and modification
There is a need for continued support such as:
— Psychosocial treatment
—Family and peer support
When relapses occur, it should signal a need for treatment to be reinstated or adjusted

4. What is ViVitrol®
(naltrexone for extended-release injectable suspension)?
ViVitrol is a once-monthly medication indicated for:
The prevention of relapse to opioid dependence, following opioid detoxification
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.
Opioid-dependent patients, including those being treated for alcohol dependence, must be opioid free at the time of initial
VIVITROL administration.
ViVitrol is an abstinence-based tool that, along with counseling, helps the process of recovery10
It is a nonaddictive, nonnarcotic, once-monthly medication
It won’t prolong dependence on opioids or alcohol
It won’t result in withdrawal when treatment is stopped
It doesn’t have a risk for abuse or diversion
ViVitrol®
provides a 1-month blockade2,3
While reversible, the blockade prevents the subjective effects of opioids, such as euphoria and reward1
Although the mechanism of action is not completely understood, this blockade is thought to prevent the increased
dopamine release responsible for the pleasurable reinforcing effects of alcohol4-7
VIVITROL will not produce dependence on opioids or alcohol and does not result in withdrawal when treatment is stopped1
No activation of the
dopamine reward system
Important Safety Information: Opioid Overdose atthe End of a Dosing Interval,
After Missing a Dose And Following an Attempt to Overcome Opioid Blockade
After opioid detoxification, patients are likely to have reduced tolerance to opioids
Patients may be more sensitive to opioids, even at lower doses, at the end of a dosing interval—near the end of the month
after VIVITROL was administered, after a dose of VIVITROL is missed or after VIVITROL treatment is discontinued
Although VIVITROL blocks the effects of exogenous opioids for 28 days after administration, cases of opioid overdose with fatal
outcomes have been reported in patients who used opioids at the end of a dosing interval or when missing a dose
This could result in life-threatening opioid intoxication (respiratory compromise or arrest, circulatory collapse, etc)
It is possible for patients to overcome the opioid blockade of VIVITROL
Although VIVITROL is an effective antagonist with a prolonged pharmacological effect, the VIVITROL blockade is surmountable
A fatal overdose may result from attempts by patients to overcome, on their own, the opioid blockade due to VIVITROL
Patients and caregivers should be alerted to the serious consequences of trying to overcome the opioid blockade
PLEASE SEE ACCOMPANYING FULL PRESCRIBING INFORMATION, INCLUDING BOXED WARNING AND MEDICATION GUIDE.
PLEASE REVIEW THE MEDICATION GUIDE WITH YOUR PATIENTS. Please see additional imPortant safety information throughout this brochure.
opioid receptor
ViVitrol®
Warning: Hepatotoxicity
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:
Important Safety Information: Contraindications
VIVITROL is contraindicated in:
Patients with acute hepatitis or liver failure
Patients receiving opioid analgesics
Patients with current physiologic opioid dependence
Patients in acute opioid withdrawal
Any individual who has failed the naloxone challenge test
or has a positive urine screen for opioids Patients who
have previously exhibited hypersensitivity to naltrexone,
polylactide-co-glycolide (PLG), carboxymethylcellulose
or any other components of the diluent
Important Safety Information: Unintended Precipitation of Opioid Withdrawal
To prevent occurrence of an acute abstinence syndrome (withdrawal) in patients dependent on opioids, or
exacerbation of a preexisting subclinical abstinence syndrome:
−Patients, including those treated for alcohol dependence, must be opioid free for a minimum of 7–10 days
before starting VIVITROL treatment
−Patients must be free of all opioid-containing medications, including medications used to treat opioid
dependence (eg, methadone, Suboxone® [buprenorphine and naloxone] Sublingual Film [Clll], Subutex®
[buprenorphine HCI sublingual tablets])
−Precipitated opioid withdrawal has been observed in alcohol-dependent patients in circumstances where
the prescriber had been unaware of the additional use of opioids or dependence on opioids

5. ViVitrol®
—rapid and Sustained Decrease in “Need for opioids”
Secondary endpoint: reduction in self-reported “need for opioids”11
Self-reported “need for opioids” was assessed with a weekly self-report visual analogue scale of 0–100; 0=not at all,
100=very much so
When treatment began (after an average of 18 days detox) the average self-reported “need for opioids” score was 20
Patients’ self-reported “need for opioids” decreased an average of 10.1 points with VIVITROL and counseling and
increased an average of 0.7 points with placebo and counseling
Mean Change in Self-Reported “Need for Opioids”
0
MeanChangeinSelf-Reported
“NeedforOpioids”Score
6
4
2
0
-2
-4
-6
-8
-10
-12
Treatment Week P<0.0001 (adjusted)
VIVITROL with psychosocial support* (n=126)
Baseline score: 18.2 (SD 22.8)
Placebo with psychosocial support* (n=124)
Baseline score: 21.8 (SD 24.2)
4 8 12 16 20 24
*Psychosocial support was defined as bi-weekly counseling.
50%DECREASE
FROM BASELINE
TO WEEK 24 WITH
VIVITROL
ViVitrol®
Helps Prevent relapse to opioid Dependence
Following opioid Detoxification
When added to counseling, ViVitrol offers patients a better chance at recovery1,8
A study showed that opioid-dependent patients who participated in counseling and took
VIVITROL had greater measured clinical improvements than patients who participated
in counseling without VIVITROL.1,8
*Complete abstinence was defined as a negative urine drug test for opioids and no self-reported opioid use.
opioid-dependent patients participating in counseling plus ViVitrol1,8
:
Had significantly more days of complete abstinence*
Stayed in treatment longer
Felt less ”Need for Opioids”
Were less likely to relapse to physical dependence
Important Safety Information: Injection Site Reactions
VIVITROL injections may be followed by pain, tenderness, induration, swelling, erythema, bruising or pruritus;
however, in some cases, injection site reactions may be very severe
In the opioid dependence pivotal trial, incidence of injection site pain was 5% in patients treated with VIVITROL
and 1% in patients treated with placebo
In alcohol clinical trials, 1 patient developed an area of induration with subsequent development of necrotic tissue
that required surgical excision
In the postmarketing period, additional cases of injection site reaction with features including induration, cellulitis,
hematoma, abscess, sterile abscess and necrosis have been reported
Some cases required surgical intervention, including debridement of necrotic tissue
— Some cases resulted in significant scarring
— The reported cases occurred primarily in female patients
— Inform patients that injection site reactions should be reported
Any signs of abscess, cellulitis, necrosis or extensive swelling must be evaluated by a physician to determine
if referral to a surgeon is warranted
Important Safety Information: Alcohol Withdrawal
Use of VIVITROL does not eliminate nor diminish alcohol withdrawal symptoms.
PLEASE SEE ACCOMPANYING FULL PRESCRIBING INFORMATION, INCLUDING BOXED WARNING AND MEDICATION GUIDE.
PLEASE REVIEW THE MEDICATION GUIDE WITH YOUR PATIENTS. Please see additional imPortant safety information throughout this brochure.
Helps Prevent relapse to opioid Dependence
When added to counseling, ViVitrol offers patients a better chance at recovery1,8
A study showed that opioid-dependent patients who participated in counseling and took
VIVITROL had greater measured clinical improvements than patients who participated
opioid-dependent patients participating in counseling plus ViVitrol1,8
:
Had significantly more days of complete abstinence*
Important Safety Information: Opioid Overdose at the End of a Dosing Interval,
After Missing a Dose,and Following an Attempt to Overcome Opioid Blockade
After opioid detoxification, patients are likely to have reduced tolerance to opioids
Patients may be more sensitive to lower doses of opioids at the end of a dosing interval—near the end of the month
after VIVITROL was administered, after a dose of VIVITROL is missed, or after VIVITROL treatment is discontinued
— Although VIVITROL blocks the effects of exogenous opioids for 28 days after administration, cases of opioid
overdose with fatal outcomes have been reported in patients who used opioids at the end of a dosing interval
or when missing a dose
—This could result in life-threatening opioid intoxication (respiratory compromise or arrest, circulatory collapse, etc)
It is possible for patients to overcome the opioid blockade of VIVITROL
Although VIVITROL is an effective antagonist with a prolonged pharmacological effect, the VIVITROL blockade is surmountable
A fatal overdose may result from attempts by patients to overcome, on their own, the opioid blockade due to VIVITROL
Patients and caregivers should be alerted to the serious consequences
of trying to overcome the opioid blockade
FPO

6. Vivitrol®
Helps Support Recovery From Alcohol Dependence
When added to counseling, VIVITROL offered patients a better chance at recovery1,9
A study showed that alcohol-dependent patients who participated in counseling and took VIVITROL,
compared to those who participated in counseling but did not take VIVITROL:
Had significantly fewer heavy drinking days*
*Heavy drinking was defined as a self-report of 5 or more standard drinks consumed on a given day for male patients
and 4 or more drinks for female patients.
Important Safety Information: Depression and Suicidality
Opioid- and alcohol-dependent individuals, including those taking VIVITROL, should be monitored for the symptoms
of depression or suicidal thinking
Families and caregivers of VIVITROL patients should be alerted to the need to monitor patients for such symptoms
and to report their occurrence to the patient’s healthcare provider
In clinical studies of opioid-dependent patients:
Adverse events of a suicidal nature (depressed mood, suicidal ideation, suicide attempt) were reported by 5%
of patients treated with VIVITROL 380 mg (n=101) and 10% of patients treated with oral naltrexone (n=20) in an
open-label, long-term safety study conducted in the United States
Adverse events involving depressed mood or suicidal thinking were not reported by any patient in either treatment group
(VIVITROL or placebo) in the 24-week pivotal opioid dependence trial conducted in Russia
Important Safety Information: Unintended Precipitation of Opioid Withdrawal
To prevent occurrence of an acute abstinence syndrome (withdrawal) in patients dependent on opioids, or exacerbation
of a preexisting subclinical abstinence syndrome:
Patients, including those treated for alcohol dependence, must be opioid free for a minimum of 7–10 days before
starting VIVITROL treatment
Patients must be free of all opioid-containingqmedications, including medications used to treat opioid dependence
(eg, methadone, Suboxone®
[buprenorphine and naloxone] Sublingual Film [Clll], Subutex®
[buprenorphine HCI
sublingual tablets])
Precipitated opioid withdrawal has been observed in alcohol-dependent patients in circumstances where
the prescriber had been unaware of the additional use of opioids or dependence on opioids
Important Safety Information: Alcohol Withdrawal
Use of VIVITROL does not eliminate nor diminish alcohol withdrawal symptoms
PLEASE SEE ACCOMPANYING FULL PRESCRIBING INFORMATION, INCLUDING BOXED WARNING AND MEDICATION GUIDE.
PLEASE REVIEW THE MEDICATION GUIDE WITH YOUR PATIENTS. Please see additional Important Safety Information throughout thIS brochure.
VIVITROL®
—More Success Maintaining Complete Abstinence
Significantly fewer drinking days and increased abstinence among the subset*
of patients who abstained from alcohol during the week prior to treatment10,13
Patients treated with VIVITROL and counseling had
13
:
Significantly more sober days
More success maintaining complete abstinence
The same results were not seen in patients who were actively drinking.
Median Drinking Days vs Days Abstinent
Baseline Placebo With Psychosocial Support†
VIVITROL With Psychosocial Support†
MedianDaysperMonth
30.2 Days
(n=17)
0
15
20
30
5
10
25
15.2 Days
6.6 Days
23.8 Days
0.2 Days
(n=17)
15.2 Days
7-Day Lead-in Abstinence Prior to Study*
P.02 vs placebo
*
n=53, or 8% of study population
†
Psychosocial support was defined as bi-weekly counseling.
Drinking days
Abstinent days
Important Safety Information: When Reversal of VIVITROL Blockade is Required for Pain Management
In an emergency situation in patients receiving VIVITROL, suggestions for pain management include:
−Regional analgesia (eg, epidural block, nerve block)
−Nonopioid analgesics (eg, acetaminophen, NSAIDs, COX-2 inhibitors)
If opioid therapy is required as part of anesthesia or analgesia:
−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 VIVITROL blockade, the patient should be monitored closely by appropriately
trained personnel in a setting equipped and staffed for cardiopulmonary resuscitation

7. ViVitrol®
Helps Support Patients through
Comprehensive Services
The VIVITROL®
Value ProgramSM
helps reduce
the financial barriers to VIVITROL therapy
Income:
There are no income requirements to be eligible
for the VIVITROL Value Program*
Co-pays and Deductibles:
Covers up to $500/month of co-pay or deductible
expenses related to VIVITROL therapy for
eligible patients* with no duration limits
Self-pay:
Patients without coverage and those who
choose not to use their prescription drug
coverage may receive a monthly discount of up
to $500 towards the purchase price of VIVITROL
TouchpointsSM
Support Services is a
free service designed to help with:
Reimbursement coverage verification
Prior authorization assistance
Submission of VIVITROL prescriptions
to specialty pharmacies
Co-pay assistance for eligible patients
Patient transition services
FDA-Approved Medications for opioid Dependence
Significance of VIVITROL
Value Program:
92%of patients utilizing
the program have no
out-of-pocket expense
for VIVITROL
PLEASE CONTACT
TOUCHPOINTS
SUPPORT SERVICES™
AT
1-800-VIVITROL
(1-800-848-4876)
Name
Molecular Structure
Abuse and Diversion
Potential
How the Medication
Works
Special Licensing
or Credential
Required?
Year Approved by
FDA for Addiction
Treatment
Typical Duration
Detoxification or
Stabilization
Controlled Substance*
Buprenorphine Methadone
Antagonist Agonist Agonist
Not Schedule Schedule III Schedule II
No Yes Yes
By blocking opioid
receptors, it blocks
cue-triggered cravings
A long-acting partial opioid,
it relieves withdrawal,
decreasescraving, and
prevents euphoria
if other opioids are used
A long-acting “full”opioid that
relieves withdrawal, blocks
craving, and prevents euphoria
if other opioids are used
No Varies by state Yes
2006 2002 1947 – Approved dispersible
tablet for treatment of addiction
Up to 30 days 1 day 1 day
Detoxification 7–10
days of complete
abstinence from opioids
Detoxification Can be used for detoxification
and/or stabilization
Adapted from Getting Stated with Medication-assisted Treatment, NIATx (2010).
Naltrexone (VIVITROL®
)
* Eligibility for Alkermes-Sponsored Co-pay Assistance: Offer valid for prescriptions for FDA-approved indications. Patients must be at least 18. Offer not valid for prescriptions
purchased under Medicaid, Medicare, TRICARE®, or any federal or state healthcare program, including any state medical or pharmaceutical assistance program. Void where
prohibited by law, taxed or restricted. Alkermes, Inc. reserves the right to rescind, revoke or amend these offers without notice.
TRICARE®
is a registered trademark of TRICARE Management Activity.
PLEASE SEE ACCOMPANYING FULL PRESCRIBING INFORMATION, INCLUDING BOXED WARNING AND MEDICATION GUIDE.
PLEASE REVIEW THE MEDICATION GUIDE WITH YOUR PATIENTS. Please see additional imPortant safety information throughout this brochure.

8. Helping People With Alcohol or opioid Dependence Move Forward
ViVitrol®
can be an important part of treating alcohol
or opioid dependence10
VIVITROL is a FDA-approved once-monthly medication designed
to be part of a comprehensive treatment program for alcohol dependence
or prevention of relapse to opioid dependence following opioid detoxification
VIVITROL once-monthly, is a nonaddictive, nonnarcotic opioid
antagonist that blocks the subjective effects of opioids
VIVITROL won’t result in withdrawal when treatment is stopped
references: 1. McLellan AT, Lewis DC, O’Brien CP, Kleber HD. Drug dependence, a chronic medical illness: implications for treatment, insurance, and outcomes evaluation. JAMA. 2000;284(13):1689-1695.
2. National Institute on Drug Abuse. Principles of Drug Addiction Treatment: A Research-based Guide (Second Edition). Bethesda, MD: National Institute on Drug Abuse, National Institutes of Health; Revised
April 2009. NIH publication 09-4180. http://www.drugabuse.gov/sites/default/files/podat_0.pdf. Accessed September 27, 2012. 3. National Institute on Drug Abuse. Drugs, Brains, and Behavior: The Science
of Addiction. Bethesda, MD: National Institute on Drug Abuse, National Institutes of Health; 2010. NIH publication 10-5605. http://www.nida.nih.gov/scienceofaddiction/sciofaddiction.pdf. Accessed September
27, 2012. 4. Fowler JS, Volkow ND, Kassed CA, Chang L. Imaging the addicted human brain. Sci Pract Perspect. 2007;3(2):4-16. 5. Myrick H, Anton RF, Li X, Henderson S, Randall PK, Voronin K. Effect of
naltrexone and ondansetron on alcohol cue-induced activation of the ventralstriatum in alcohol-dependent people. Arch Gen Psychiatry. 2008;65(4):466-475. 6. Oswald LM, Wand GS. Opioids and alcoholism.
Physiol Behav. 2004;81(2):339-358. 7. Volkow ND, Fowler JS, Wang GJ, Goldstein RZ. Role of dopamine, the frontal cortex and memory circuits in drug addiction: insight from imaging studies. Neurobiol
Learn Mem. 2002;78(3):610-24. 8. Pettinati HM, Volpicelli JR, Pierce JD Jr, O’Brien CP. Improving naltrexone response: an intervention for medical practitioners to enhance medication compliance in alcohol
dependent patients. J Addict Dis. 2000;19(1):71-83. 9. Substance Abuse and Mental Health Services Administration, Center for Behavioral Health Statistics and Quality. Treatment Episode Data Set (TEDS):
2000-2010. National Admissions to Substance Abuse Treatment Services. DASIS SeriesS-61, HHS Publication No. (SMA) 12-4701. Rockville, MD: Substance Abuse and Mental Health Services Administration,
2012. 10. VIVITROL [full prescribing information]. Waltham, MA: Alkermes, Inc; rev October 2010. 11. Krupitsky E, Nunes EV, Ling W, Illeperuma A, Gastfriend DR, Silverman BL. Injectable extended-release
naltrexone for opioid dependence: a double-blind, placebo-controlled, multicentre randomised trial. Lancet. 2011(9776);377:1506-1513. 12. Garbutt JC, Kranzler HR, O’Malley SS, et al, for the Vivitrex Study
Group. Efficacy and tolerability of long-acting injectable naltrexone for alcohol dependence: a randomized controlled trial. JAMA. 2005;293(13):1617-1625. 13. Data on file. Alkermes, Inc.
PLEASE SEE ACCOMPANYING FULL PRESCRIBING INFORMATION, INCLUDING BOXED WARNING AND MEDICATION GUIDE.
PLEASE REVIEW THE MEDICATION GUIDE WITH YOUR PATIENTS.
Alkermes®
and VIVITROL®
are registered trademarks of Alkermes, Inc.
©2013 Alkermes, Inc.
All rights reserved VIV-XXXXXX Printed in U.S.A.
www.vivitrol.com
FPO
Additional Important Safety Information
When reversal of ViVitrol Blockade is
required for Pain Management:
In an emergency situation in patients receiving VIVITROL,
suggestions for pain management include regional
analgesia or use of non-opioid analgesics.
Depression and Suicidality:
VIVITROL patients should be monitored for the
development of depression or suicidal thinking.
Eosinophilic Pneumonia:
VIVITROL patients should be warned of the risk of
eosinophilic pneumonia, and advised to seek medical
attention should they develop symptoms of pneumonia.
Hypersensitivity Reactions Including
Anaphylaxis:
Patients should be warned of the risk of hypersensitivity
reactions, including anaphylaxis.
intramuscular injections:
VIVITROL should be administered with caution to
patients with thrombocytopenia or any coagulation
disorder.
Common Side Effects in People taking
ViVitrol for opioid Dependence include:
Nausea, tiredness, headache, dizziness, vomiting,
decreased appetite, painful joints, and muscle cramps.
Common Side Effects in People taking
ViVitrol for Alcohol Dependence include:
Nausea, tiredness, headache, dizziness, vomiting,
decreased appetite, painful joints, and muscle cramps.
FPOFPOFPO
to be part of a comprehensive treatment program for alcohol dependence
or prevention of relapse to opioid dependence following opioid detoxification
FPOFPO