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Click Here for Indications 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 prevent relapse to opioid dependence in your appropriate opioid-detoxed patients1,2

The efficacy of VIVITROL in the treatment of opioid dependence was evaluated in a 24-week, placebo-controlled, multicenter, double-blind, randomized trial of opioid-dependent (DSM-IV) outpatients who were completing or had recently completed detoxification.


Endpoints2

The primary endpoint was confirmed opioid abstinence during Weeks 5-24.

  • Confirmed abstinence was defined as a negative urine drug test (UDT) for opioids and no self-reported drug use
  • Weeks 1-4 were omitted from the endpoint to allow for stabilization of abstinence

With VIVITROL and counseling, 36% of patients in the pivotal trial maintained complete abstinence for Weeks 5-24 vs 23% with placebo and counseling1,2

Subject sustaining varying percentages of opioid-free weeks*

Percentage of opioid-free patients chart
  • Data were not collected during Weeks 1-4 of the trial to allow for stabilization of abstinence.
  • The median of the VIVITROL group had confirmed abstinence* for 90% of the weeks in the evaluation period vs 35% for the median of the placebo group.
*Confirmed abstinence or “opioid-free” was defined as a negative UDT for opioids and no self-reported opioid use. Psychosocial support consisted of biweekly counseling sessions of individual drug counseling, adapted for opioid dependence. Data represented as the median. Please see study limitations.

Secondary endpoints

Secondary endpoints were self-reported opioid-free days, opioid craving scores, treatment retention data, and relapses to physiological opioid dependence.

Secondary endpoint: Mean change in opioid craving

Mean change in self-reported opioid craving in patients receiving VIVITROL and counseling vs placebo2,3

Patients given VIVITROL had a -10.1 mean change in craving visual analog scale (VAS) score, while patients given placebo had a +0.7 change in craving VAS score.

Mean change in self-reported craving score

Mean change in self-reported craving chart

Patients in the VIVITROL group had a 55% lower mean craving score at 24 weeks than the mean score at baseline. Patients in the placebo group had a 3% higher mean craving score at 24 weeks than the mean score at baseline.3

Craving (described as a “need for opioids”) was self-reported weekly according to a VAS of 0 to 100, with 0 being “not at all” and 100 being “very much so.” Psychosocial support consisted of biweekly sessions of individual drug counseling, adapted for opioid dependence.

Secondary endpoint: Number of days of retention

Number of days of retention Number of days of retention §Psychosocial support consisted of bi-weekly counseling sessions of individual drug counseling, adapted for opioid dependence. Median number of days of retention >168 days for patients (n=67) who continued into the open-label long-term extension study.

Secondary endpoint: Number of patients with a positive naloxone challenge at the end of 24 weeks: 1 VIVITROL patient vs 17 placebo patients.

Other Outcomes

A greater percentage of subjects in the VIVITROL group (53%, n=67) remained in the study compared to the placebo group (38%, n=47; =0.0171).

Please see study limitations.

Study design2

Prior to treatment initiation, patients were voluntarily seeking treatment, completing ≤30 days of inpatient opioid detoxification and not taking opioids for at least 7 days.

Participants were randomized to receive VIVITROL (n=126) or placebo (n=124), with a UDT every week, psychosocial support every 2 weeks, and treatment injection every 4 weeks.

After randomization, there was a 4-week period for treatment engagement during which opioid use, if it occurred, was allowed. This period was not included in the analysis. Subjects provided additional self-report of opioid use.

VIVITROL (n=126) Placebo (n=124)
Age in years 29.4 (±4.8) 29.7 (±3.6)
Men 113 (90%) 107 (86%)
White 124 (98%) 124 (100%)
Duration of opioid dependence in years 9.1 (±4.5) 10.0 (±3.9)
Days of prestudy inpatient detoxification 18 (±9) 18 (±7)
Opioid craving scale 18 (±23) 22 (±24)
HIV serology positive 51 (40%) 52 (42%)
Hepatitis C positive 111 (88%) 117 (94%)

Data are mean (SD) or number (%).

  • Retention in the placebo group might have been reduced by recognition, upon opioid use, that one was on placebo
    • Or, among patients in the placebo group who had relapsed to regular opioid use, by reluctance to return to the clinic and face a withdrawal reaction from a naloxone challenge test
  • The placebo group showed a substantial retention and response profile, and a markedly higher rate of positive naloxone challenge tests
  • The high retention rate might have been influenced by:
    • Inclusion criterion that patients have someone available to supervise attendance
    • Provision of individual counselling
    • Absence of alternative treatments in Russia
    • Promise of active VIVITROL treatment for all patients after 6 months, in the subsequent open-label extension safety study
  • Analyses of group central tendencies (median, mean) may not reflect the experience of individual patients

Adverse reactions in opioid dependence pivotal trial

Treatment-emergent adverse reactions (occurring in ≥2% of patients and more frequently in the VIVITROL group than the placebo group) in the pivotal trial for opioid dependence1

Events VIVITROL 380 mg with psychosocial support (n=126) Placebo with psychosocial support (n=124)
Alanine aminotransferase increased 13% 6%
Aspartate aminotransferase increased 10% 2%
Gamma-glutamyltransferase increased 7% 3%
Nasopharyngitis 7% 2%
Insomnia 6% 1%
Influenza 5% 4%
Hypertension 5% 3%
Injection site pain 5% 1%
Toothache 4% 2%
Headache 3% 2%

Please see the complete list of adverse reactions in the VIVITROL
Prescribing Information.

Discontinuation rates due to adverse events1

Opioid dependence pivotal trial

Discontinuation rate bar chart Psychosocial support consisted of biweekly session of individual drug counseling, adapted for opioid dependence.

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References: 1. VIVITROL [prescribing information]. Waltham, MA: Alkermes, Inc; rev March 2021. 2. 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;377(9776):1506-1513. 3. Data on file. Alkermes, Inc. Waltham, MA.

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References: 1. VIVITROL [prescribing information]. Waltham, MA: Alkermes, Inc; rev March 2021. 2. 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;377(9776):1506-1513. 3. Data on file. Alkermes, Inc. Waltham, MA.

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