Help your patients prevent relapse to opioid dependence, after detoxification

VIVITROL and counseling may help prevent relapse to opioid dependence in your appropriate opioid-detoxed patients.^1,2

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.^1,2

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

Pivotal study endpoint²

The primary endpoint was confirmed opioid abstinence^a 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

A greater percentage of patients maintained complete abstinence for Weeks 5-24 with VIVITROL and counseling vs placebo and counseling^1,2

36%

with VIVITROL and counseling (45/126)

23%

with placebo and counseling (28/124)

P=0.0224

Subjects sustaining varying percentages of opioid-free weeks^1,2,a

Percentage of opioid-free patients chart.

The VIVITROL group had confirmed abstinence^a for a median of 90% of the weeks in the evaluation period vs a median of 35% for the placebo group²

^aConfirmed abstinence or opioid-free was defined as a negative UDT for opioids and no self-reported opioid use. ^bPsychosocial support consisted of biweekly counseling sessions of individual drug counseling, adapted for opioid dependence. See study design.
Please see study limitations.

Secondary endpoints

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

Opioid craving^2,3

Patients given VIVITROL had a -10.1 mean change in craving visual analog scale (VAS) score, whereas patients given placebo had a +0.7 change in craving VAS score from baseline.²

mean change in craving visual analog scale (VAS) score²

-10.1

with VIVITROL and counseling (n=126)

+0.7

with placebo and counseling (n=124)

Mean change in self-reported craving score²

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

^cCraving (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.” ^dPsychosocial support consisted of biweekly sessions of individual drug counseling, adapted for opioid dependence.

Number of days of retention^2,4

^ePsychosocial support consisted of biweekly sessions of individual drug counseling, adapted for opioid dependence.

^fMedian number of days of retention >168 days for patients (n=67) who continued into the open-label, long-term extension study.

Number of patients with a positive naloxone challenge at the end of 24 weeks: 1 VIVITROL patient vs 17 placebo patients²

Please see study limitations.

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^g (n=126)	Placebo with psychosocial support^g (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. ^gPsychosocial support was defined as biweekly counseling.

Discontinuation rates due to adverse events¹

Opioid dependence pivotal trial

^hPsychosocial support consisted of biweekly sessions of individual drug counseling, adapted for opioid dependence.

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 urine drug test 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.

Study limitations²

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 counseling
- 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

Demographics and baseline characteristics²

	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 (%).

Other outcomes²

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

Opioid Dependence:
VIVITROL^® Efficacy
and Safety Data

Help your patients prevent relapse to opioid dependence, after detoxification