OPIOID DEPENDENCE DATA

A 24-week, multicenter, double-blind, randomized, placebo-controlled trial of opioid-dependent (DSM-IV) outpatients, ≥18 years of age^1,2

PIVOTAL STUDY DATA^1,2

• 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)
  • Every week—urine drug test
  • Every 2 weeks—psychosocial support
  • Every 4 weeks—treatment injection

OPIOID STUDY DESIGN¹

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.

EXCLUSION CRITERIA

• Past/present history of an AIDS-indicator disease
• Evidence of hepatic failure
• Active hepatitis and/or aspartate aminotransferase or alanine aminotransferase >3 times the upper limit of normal

ENDPOINTS EVALUATING
THE EFFICACY OF VIVITROL¹

DEMOGRAPHICS AND CLINICAL BASELINE CHARACTERISTICS

Data are mean (standard deviation [SD]) or number (%)

PRIMARY ENDPOINT:
COMPLETE OPIOID ABSTINENCE^1,2*

With VIVITROL and counseling, more patients achieved complete abstinence vs placebo.

• Complete abstinence was sustained by 36% of VIVITROL patients (n=45) compared with 23% of patients treated with placebo (n=28), during Weeks 5-24 (P=0.0224)

SUBJECTS SUSTAINING VARYING PERCENTAGES OF OPIOID-FREE WEEKS

• 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

*Complete or confirmed abstinence was defined as a negative urine drug test for opioids and no self-reported opioid use. ^†Psychosocial support consisted of bi-weekly counseling sessions of individual drug counseling, adapted for opioid dependence. Data were not collected during Weeks 1-4 of the trial to allow for stabilization of abstinence.

SECONDARY ENDPOINT:
SELF-REPORTED OPIOID-FREE^‡ DAYS

Patients treated with VIVITROL and counseling had 99.2% opioid-free days¹

• The median of the VIVITROL group reported 99.2% opioid-free days compared with 60.4% in the placebo group¹
• The median number of opioid-free days at baseline was zero for both the VIVITROL and placebo groups³

THE MEDIAN OF THE VIVITROL GROUP HAD 99.2%
OPIOID-FREE DAYS DURING WEEKS 1–24¹

^‡"Opioid-free" was defined as no self-reported opioid use. ^§Psychosocial support consisted of bi-weekly counseling sessions of individual drug counseling, adapted for opioid dependence.

SECONDARY ENDPOINT: CRAVING

In a pivotal trial, patients treated with VIVITROL experienced a reduction in opioid craving vs placebo.¹

• Craving (described as a "need for opioids") was reported weekly according to a visual analogue scale (VAS) of 0–100, with 0 being “none” and 100 "very much so"¹
• A statistically and clinically significant reduction in opioid craving was observed with VIVITROL vs placebo by Week 8 (P=0.0048), which persisted every week through Week 24 (P<0.0001, adjusted)¹
• Patients treated with VIVITROL had an average 10.1 decrease in baseline craving as measured by the VAS score, while patients who received placebo had a 0.7 increase in baseline craving as measured by VAS score (P<0.0001, adjusted)¹

MEAN CHANGE IN SELF-REPORTED CRAVING^1,3

Change in Mean Craving Score³

• VIVITROL: 55% lower mean craving score at 24 weeks compared to baseline
• Placebo: 3% higher mean craving score at 24 weeks compared to baseline

^IIPsychosocial support consisted of bi-weekly counseling sessions of individual drug counseling, adapted for opioid dependence.

SECONDARY ENDPOINT:
TREATMENT RETENTION¹

Among opioid-dependent patients treated with VIVITROL and counseling, median time in treatment was 1.7x longer than with placebo.

• Patients receiving VIVITROL were significantly more likely to complete 6 months of treatment (n=67, 53%) compared with those receiving placebo (n=47, 38%; P=0.0171)
• At the end of the study period (168 days), the median of the VIVITROL group had not dropped out¹
  • The median time in treatment was >168 days for VIVITROL patients vs 96 days with placebo

THE MEDIAN OF THE VIVITROL GROUP HAD LONGER TREATMENT RETENTION VS PLACEBO

^¶Psychosocial support consisted of bi-weekly counseling sessions of individual drug counseling, adapted for opioid dependence.

SECONDARY ENDPOINT: RELAPSE TO PHYSIOLOGICAL OPIOID DEPENDENCE

Only 1 patient on VIVITROL (<1%) discontinued due to positive naloxone challenge, indicating physical dependence had been re-established, compared to 17 patients on placebo (14%)¹

ADVERSE REACTIONS IN OPIOID-DEPENDENCE CLINICAL STUDIES²

ADVERSE REACTIONS

Adverse reactions that occurred in ≥2% of patients with opioid dependence treated with VIVITROL and occurred more frequently in the VIVITROL group vs the placebo group.

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

DISCONTINUATION RATE

Discontinuation rates due to adverse events were similar in opioid-dependent patients treated with VIVITROL vs patients treated with placebo.

VIVITROL is not right for everyone. There are significant risks from VIVITROL treatment, including risk of opioid overdose, injection site reactions and sudden opioid withdrawal.
See Important Safety Information below. Discuss all benefits and risks with your patients. See Prescribing Information and Medication Guide with your patients.