OPIOID DEPENDENCE
EFFICACY AND SAFETY

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

Opioid study design

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

PRIMARY ENDPOINT:
CONFIRMED OPIOID ABSTINENCE

Response profile of patients who achieved complete abstinence during weeks 5–24

  • Confirmed abstinence or "opioid-free" was defined as a negative urine drug test for opioids and no self-reported opioid use
  • Weeks 1-4 were omitted from this endpoint to allow for stabilization of abstinence

SECONDARY ENDPOINTS

  • Self-reported opioid-free days
  • Craving
  • Treatment retention
  • Relapse to physiologic opioid dependence

DEMOGRAPHICS AND CLINICAL BASELINE CHARACTERISTICS

  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 pre-study 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 (%)


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 5–241-3

Percentage of opioid-free patients chart

*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

60.4% opioid-free days during weeks 1-24 on placebo

Placebo
with Psychosocial Support** (n=124)

P=0.0004

99.2% opioid-free days during weeks 1-24 on VIVITROL®

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 CRAVING1,3

Mean change in self-reported craving chart

**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

Time in treatment bar chart

**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

94% fewer
naloxone-confirmed relapses to dependence1

Treatment retention
is one of the most important indicators of medication-assisted treatment outcomes3


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.

  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 complete list of adverse events in the VIVITROL Prescribing Information.

DISCONTINUATION RATE

Discontinuation rate bar chart

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

DOWNLOAD THE VIVITROL BROCHURE

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.

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REQUEST A REPRESENTATIVE

Request a visit from a VIVITROL representative to learn more about how VIVITROL may help your opioid- and alcohol-dependent patients.

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VIVITROL® Co-pay Savings Program

LEARN ABOUT THE VIVITROL® CO-PAY SAVINGS PROGRAM

Learn how the VIVITROL® Co-pay Savings Program may assist eligible* patients with out-of-pocket expenses for their VIVITROL prescriptions.

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References:

  1. 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.
  2. VIVITROL [prescribing information and medication guide]. Waltham, MA: Alkermes, Inc; rev December 2015.
  3. Data on file. Alkermes, Inc.
*Eligibility for Alkermes-Sponsored Co-pay Assistance: Offer valid only for prescriptions for FDA-approved indications. You must be at least 18 years old. If you are purchasing your VIVITROL prescriptions with benefits from Medicare, including Medicare Part D or Medicare Advantage plans; Medicaid, including Medicaid Managed Care or Alternative Benefit Plans (“ABPs”) under the Affordable Care Act; Medigap; Veterans Administration (“VA”); Department of Defense (“DoD”); TriCare®; or any similar state funded programs such as medical or pharmaceutical assistance programs, you are not eligible for this offer. Void where prohibited by law, taxed or restricted. Alkermes, Inc. reserves the right to rescind, revoke, or amend these offers without notice.