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.
  • The prevention of relapse to opioid dependence, following opioid detoxification.

VIVITROL should be part of a comprehensive management program that includes psychosocial support.

VIVITROL and counseling may help your appropriate patients with alcohol dependence achieve fewer heavy drinking days1

The efficacy of VIVITROL in the treatment of alcohol dependence was evaluated in a 24-week, placebo-controlled, multicenter, double-blind, randomized trial of patients with alcohol dependence (DSM-IV criteria) in an outpatient setting.2

DSM-IV=Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition.

Primary endpoint2

The primary endpoint was the event rate of heavy drinking over the 24 weeks of treatment, defined as the number of heavy-drinking days divided by the number of days at risk for heavy drinking.2

Patients in the VIVITROL and counseling group had a greater reduction in days of heavy drinking than those in the placebo and counseling group.1,2

25%

Fewer heavy drinkinga
days per month
vs placebo2

VIVITROL 380 mg (n=205) vs placebo (n=209); HR=0.75 (0.60-0.94); P=0.02.

HR=hazard ratio.

aHeavy drinking was defined as a self-report of ≥5 standard drinks consumed on a given day for male patients and ≥4 for female patients.

See study design.
Please see study limitations.

Subset analysis1,2

A predefined subpopulation of lead-in abstinent patients (n=53, or 8% of the total study population) was defined as those who reported no drinking during the 7 consecutive days preceding the first injection.

Among the subset of patients, those treated with VIVITROL 380 mg had greater reductions than placebo-treated patients in the number of drinking days and the number of heavy drinking days.

The same treatment effects were not evident among the subset of patients (n=571, 92% of the total study population) who were actively drinking at the time of treatment initiation.

In the subset population

Heavy drinking days1,2,b

Median heavy drinking days: ≥7-day abstinent subset (n=53) over 6 months

Heavy drinking days bar chart.

bHeavy drinking was defined as a self-report of ≥5 standard drinks consumed on a given day for male patients and ≥4 for female patients.

cPsychosocial support was defined as biweekly counseling.2

In the subset population

Any drinking days1

Median any drinking days per month: ≥7-day abstinent subset (n=53) over 6 months4

Any drinking days bar chart.

At baseline, the median 7-day abstinent patient had 15.2 drinking days and 15.2 abstinent days per average month (30.4 days).4

In the subset population

Complete abstinence throughout treatment1-3

Patients maintaining complete abstinence (%): ≥7-day abstinent subset (n=53)
over 6 months

Complete abstinence bar chart.

A greater proportion of patients with 7-day lead-in abstinence on VIVITROL maintained abstinence throughout the 6-month study period vs those on placebo.

dPsychosocial support was defined as biweekly counseling.
Please see study limitations.

Adverse reactions in alcohol dependence pivotal trial1

Treatment-emergent adverse reactions that occurred in ≥5% of patients with alcohol dependence treated with VIVITROL and that occurred more frequently in the VIVITROL group vs the placebo group

VIVITROL
380 mg with psychosocial supporte (n=205)		 Placebo
with psychosocial supporte (n=214)
Any ISR 69% 50%
Injection site tenderness 45% 39%
Injection site induration 35% 8%
Nausea 33% 11%
Headache 25% 18%
Asthenic conditions 23% 12%
Injection site pain 17% 7%
Other ISR (primarily nodules, swelling) 15% 4%
Insomnia, sleep disorder 14% 12%
Vomiting NOS 14% 6%
Anorexia, appetite decreased NOS,
appetite disorder NOS		 14% 3%
Diarrhea 13% 10%
Dizziness, syncope 13% 4%
Anxiety 12% 8%
Arthralgia, arthritis, joint stiffness 12% 5%
Pharyngitis 11% 11%
Abdominal pain 11% 8%
Injection site pruritus 10% 0%
Depression 8% 4%
Muscle cramps 8% 1%
Injection site ecchymosis 7% 5%
Back pain, back stiffness 6% 5%
Rash 6% 4%
Dry mouth 5% 4%
Somnolence, sedation 4% 1%
ISR=injection site reaction; NOS=not otherwise specified. ePsychosocial support was defined as biweekly counseling.

Discontinuation rates due to adverse events1

Alcohol dependence controlled clinical trial of ≤6 months

Discontinuation rate bar chart. fPsychosocial support was defined as biweekly counseling.

Study design2

Patients met the DSM-IV criteria for alcohol dependence and had a minimum of 2 episodes of heavy drinking per week in the 30 days before screening. Heavy drinking was defined as ≥5 standard drinks per day for men and ≥4 standard drinks per day for women.

Participants received an intramuscular injection every 4 weeks in an outpatient setting for a total of 6 injections over 24 weeks, along with psychosocial support every other week. A total of 208 patients were randomized to the VIVITROL 380 mg group. Three patients did not receive any treatment due to enrollment failures based on investigator decision, leaving 205 patients included in the primary analysis and safety evaluation for the VIVITROL 380 mg group. A total of 209 patients were randomized to the placebo group.

Study limitations2,3

  • Men and women in this study differed on a number of important variables, including the prevalence of smoking and antidepressant use, weight, and commitment to abstinence
  • The men and women in this sample may have differed on other variables that may positively influence naltrexone response but were not assessed in this study, such as family history of alcoholism
  • The study was not designed to answer whether naltrexone may or may not work for women
  • The women who participated may not be representative of women with alcohol dependence in the general population, and the number of women studied was small
  • Clinical trials may enroll patients with a greater degree of motivation for change than is seen among patients who are treated in traditional outpatient settings
  • Although treatment attendance was relatively high in this study, dropouts reduce the extent to which the findings generalize to all of those with alcohol dependence. Drinking data for dropouts were not obtained once they left the study, so it is not known how these drinking outcomes would have affected the results
  • Analyses of group central tendencies (median, mean) do not reflect the experience of individual patients

Subset analysis limitations1,2:

  • Due to the small numbers, this analysis should be interpreted with caution
  • The same treatment effects were not evident among the subset of patients (n=571, 92% of the total study population) who were actively drinking at the time of treatment initiation
  • Secondary data analysis. No adjustments were made for multiple comparisons; therefore, treatment differences could represent chance findings

Demographics and baseline characteristics2

VIVITROL
380 mg (n=205)		 Placebo
(n=209)
Mean age in yearsg 45.0 (±10.1) 44.7 (±10.8)
White 172 (83.9%) 180 (86.1%)
Mean weight in kgg 84.2 (±20.7) 81.6 (±17.0)
Employed ≥20 hours/week 144 (70.2%) 151 (72.2%)
Other drug use
Current smokerg 99 (48.3%) 88 (42.1%)
Antidepressants 62 (30.2%) 61 (29.2%)
Drinking behavior
Patient treatment goal of total abstinence 90 (43.9%) 90 (43.1%)
Abstinence for 7 days before randomization 17 (8.3%) 19 (9.1%)
Self-help group attendanceg 24 (11.7%) 23 (11.0%)
Mean % heavy drinking days in 30 days before randomization 64.0% (±25.9) 65.2% (±24.8)
gP<0.05 (significant difference between men and women in the overall study population [N=624]).

Pivotal study post hoc analysis

A post hoc analysis of a subset of patients in the pivotal trial who were able to abstain completely from drinking for the 4 consecutive days prior to first injection3

This post hoc analysis was not prespecified and included a small sample size; thus, the results could represent chance findings and should be interpreted with caution. A post hoc analysis of the alcohol dependence pivotal trial was performed on data from 624 outpatients with alcohol dependence who were randomly assigned to receive VIVITROL 380 mg, XR-NTX 190 mg, or placebo every 4 weeks for 24 weeks, along with psychosocial support every other week. In the subanalysis, 82 patients were voluntarily abstinent for ≥4 days prior to treatment initiation. Evaluations occurred weekly for the first 4 weeks and then every 2 weeks for the next 20 weeks until the final visit.

Median heavy drinkingh days per month: ≥4-day abstinent subset (n=82)3

  • VIVITROL 380 mg with psychosocial supporti (n=28): 0.2 heavy drinking days
  • Placebo with psychosocial supporti (n=28): 2.9 heavy drinking days

Median number of days to first heavy drinking event: ≥4-day abstinent subset population (n=82)3,4

Heavy drinking days per month in subset. hHeavy drinking was defined as a self-report of ≥5 standard drinks consumed on a given day for male patients and ≥4 for female patients. iPsychosocial support was defined as biweekly counseling.
Please see study limitations.
Watch their videos
EXPLORE DOSING

return to top

References: 1. VIVITROL [Prescribing Information]. Alkermes, Inc. 2. Garbutt JC, Kranzler HR, O’Malley SS, et al. Efficacy and tolerability of long-acting injectable naltrexone for alcohol dependence: a randomized controlled trial. JAMA. 2005;293(13):1617-1625. doi:10.1001/jama.293.13.1617 3. O’Malley SS, Garbutt JC, Gastfriend DR, Dong Q, Kranzler HR. Efficacy of extended-release naltrexone in alcohol-dependent patients who are abstinent before treatment. J Clin Psychopharmacol. 2007;27:507-512. doi:10.1097/jcp.0b013e31814ce50d 4. Data on file. Alkermes, Inc. Waltham, MA.

return to top

References: 1. VIVITROL [Prescribing Information]. Alkermes, Inc. 2. Garbutt JC, Kranzler HR, O’Malley SS, et al. Efficacy and tolerability of long-acting injectable naltrexone for alcohol dependence: a randomized controlled trial. JAMA. 2005;293(13):1617-1625. doi:10.1001/jama.293.13.1617 3. O’Malley SS, Garbutt JC, Gastfriend DR, Dong Q, Kranzler HR. Efficacy of extended-release naltrexone in alcohol-dependent patients who are abstinent before treatment. J Clin Psychopharmacol. 2007;27:507-512. doi:10.1097/jcp.0b013e31814ce50d 4. Data on file. Alkermes, Inc. Waltham, MA.

return to top