OPIOID DEPENDENCE DATA

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

PIVOTAL STUDY DATA

• 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.^1,2 Subjects provided additional self-report of opioid use.¹

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 (SD) or number (%)

PRIMARY ENDPOINT:
MORE PATIENTS REMAINED OPIOID-FREE*

With VIVITROL and counseling, more patients achieved complete abstinence

• Complete abstinence was sustained by 36% (n=45) of VIVITROL patients compared with 23% (n=28) of patients treated with placebo, during weeks 5–24 (P=0.0224)^1,2
• The median VIVITROL patient had confirmed abstinence for 90% of the weeks in the evaluation period vs. 35% for the median placebo patient (P=0.0002)¹

PERCENTAGE OF OPIOID-FREE PATIENTS THROUGH WEEKS 5–24^1-3

*Confirmed abstinence or “opioid-free” 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 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 days

• Patients in the VIVITROL group reported a median of 99.2% opioid-free days compared with 60.4% in the placebo group (P=0.0004)¹
• The median number of opioid-free days at baseline was zero for both the VIVITROL and placebo groups³

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

Placebo
with Psychosocial Support** (n=124)

P=0.0004

VIVITROL
with Psychosocial Support** (n=126)

†"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

Opioid-dependent patients treated with VIVITROL and counseling had a progressive and sustained decrease in craving.¹

• Craving (described as a "need for opioids") was reported weekly according to a visual analog 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 24 (P<0.0001)¹
• VIVITROL patients had a mean change from baseline of -10.1 points vs. a mean change of +0.7 points for patients in the placebo group over 6 months (baseline mean VAS score=20)¹
  • Patients given VIVITROL had a 55% decrease in craving from baseline to week 24
  • Patients given a placebo had a 3% increase in craving from baseline to week 24

MEAN CHANGE IN SELF-REPORTED CRAVING^1,3

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

SECONDARY ENDPOINT:
TREATMENT RETENTION

Among opioid-dependent patients treated with VIVITROL and counseling, treatment retention was 1.7x longer

• VIVITROL helped significantly more patients complete treatment (24 weeks; n=67, 53%) compared with placebo (n=47, 38%; P=0.0171)¹
• At the end of the study period (168 days), the median VIVITROL patient had not dropped out¹
• The median time in treatment was >168 days in VIVITROL patients (vs. 96 days with placebo)¹

PATIENTS ON VIVITROL HAD LONGER TREATMENT RETENTION THAN PLACEBO¹

**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%; P<0.0001)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.