ALCOHOL DEPENDENCE
EFFICACY AND SAFETY

A 24-week, multicenter, double-blind, randomized, placebo-controlled trial1,2

  • Patients met the DSM-IV criteria for active alcohol dependence and had a minimum of 2 episodes of heavy drinking per week in the 30 days before screening1,2
    • Heavy drinking was defined as ≥5 standard drinks per day for men and ≥4 standard drinks per day for women
  • 627 patients were randomized to receive VIVITROL 380 mg (n=208), VIVITROL 190 mg (n=210), or placebo (n=209)1
  • Participants received an intramuscular injection every 4 weeks—a total of 6 injections over 24 weeks1,2
    • Patients also received psychosocial support every other week

ALCOHOL STUDY DESIGN1,2

Alcohol study design

*17 Abstained 7 days prior to treatment †19 Abstained 7 days prior to treatment


PRIMARY ENDPOINT: THE EVENT RATE OF HEAVY DRINKING1

THE PRIMARY ENDPOINT WAS THE EVENT RATE OF HEAVY DRINKING OVER THE 24 WEEKS

  • Defined as the number of heavy-drinking days divided by the number of days at risk for heavy drinking

SUBSET POPULATION1-3

A predefined subpopulation of lead-in abstinent patients (n=53, or 8% of the total study population; P=0.005) was defined as those who reported no drinking during the 7 consecutive days preceding the first injection.

BASELINE CHARACTERISTICS

  VIVITROL 380 mg
(n=205)
Placebo
(n=209)
Demographics
Mean age in years 45.0 (±10.1) 44.7 (±10.8)
White 172 (83.9%) 180 (86.1%)
Mean weight in kg 84.2 (±20.7) 81.6 (±17.0)
Employed ≥20h/wk 144 (70.2%) 151 (72.2%)
Other drug use
Current smoker 99 (48.3%) 88 (42.1%)
Antidepressants 62 (30.2%) 61 (29.2%)
Drinking behavior
Abstinence goal 90.0 (43.9%) 90.0 (43.1%)
Abstinence for 7 days before randomization 17 (8.3%) 19 (9.1%)
Self-help group attendance 24 (11.7%) 23 (11.0%)
Mean % heavy drinking in 30 days before randomization 64.0% (±25.9) 65.2% (±24.8)

Data are mean (SD) or number (%)


P<0.05 (significant difference between men and women in the overall study population [n=624]).


PRIMARY ENDPOINT: EVENT RATE OF HEAVY DRINKING

Patients treated with VIVITROL and counseling demonstrated a significant reduction in heavy-drinking days1

Heavy drinking was defined as a self-report of 5 or more standard drinks consumed on a given day for male patients and 4 or more drinks for female patients.1

OVERALL TREATMENT POPULATION

In the overall treatment population, patients treated with VIVITROL 380 mg (n=205) demonstrated a 25% greater reduction in days of heavy drinking than those treated with placebo (n=209; HR=0.75 [0.60–0.94]; P=0.02)1

SUBSET POPULATION1-3

Fewer days of heavy drinking in patients who abstained prior to treatment

  • In the prespecified subset analyses (n=53, or 8% of the total study population), the median patient who abstained for 7 days prior to randomization had significantly fewer heavy-drinking days in the average month vs. those treated with placebo during the 6-month study3
  • The same treatment effects were not evident in the subset of patients who were actively drinking at the time of treatment initiation3

WITHIN SUBSET, 92% FEWER DAYS OF HEAVY DRINKING WITH VIVITROL1,3

Heavy drinking days per month bar graph

§Psychosocial support was defined as bi-weekly counseling.


SUBSET POPULATION:
EVENT RATE OF ANY-DRINKING DAYS3

Patients treated with VIVITROL and psychosocial counseling saw significant reductions in median drinking days for the average month during the 6-month trial.

WITHIN THE SUBSET OF PATIENTS WHO ABSTAINED FROM DRINKING 7 DAYS PRIOR TO TREATMENT, 97% FEWER ANY-DRINKING DAYS WITH VIVITROL

Any-drinking days per month bar chart

§Psychosocial support was defined as bi-weekly counseling.
At baseline, the median 7-day abstinent patient had 15.2 drinking days and 15.2 abstinent days per average month (30.4 days).


SUBSET POPULATION: EVENT RATE OF ABSTINENT DAYS AND COMPLETE ABSTINENCE FROM ALCOHOL3

WITHIN THE SUBSET OF PATIENTS WHO ABSTAINED FROM DRINKING PRIOR TO TREATMENT, VIVITROL PATIENTS HAD A GREATER NUMBER OF ABSTINENT DAYS IN AN AVERAGE MONTH

Abstinent days per average month bar chart

The median patient treated with VIVITROL who had a 7-day lead-in abstinence had an increase in the number of abstinent days compared to placebo throughout the 6-month study.

Within the subset, more patients had maintained continuous abstinence on VIVITROL

Percent of patients maintaining continuous abstinence bar chart

There was a greater proportion of patients with a 7-day lead-in abstinence on VIVITROL who maintained abstinence throughout the 6-month study period vs. those treated with placebo.


§Psychosocial support was defined as bi-weekly counseling. At baseline, the median 7-day abstinent patient had 15.2 drinking days and 15.2 abstinent days per average month (30.4 days).


ADVERSE REACTIONS IN
ALCOHOL-DEPENDENCE CLINICAL STUDIES2

Adverse reactions that occurred in ≥5% of patients with alcohol dependence treated with VIVITROL and occurred more frequently in the VIVITROL group vs. the placebo group

ADVERSE REACTIONS

  VIVITROL 380 mg
with Psychosocial
Support (n=205)
Placebo
with Psychosocial
Support (n=214)
Any ISR 69% 50%
Injection site tenderness 45% 39%
Injection site induration 35% 8%
Nausea 33% 11%
Headache 25% 18%
Asthenic conditions 23% 12%
Injection site pain 17% 7%
Other ISR (primarily nodules, swelling) 15% 4%
Insomnia, sleep disorder 14% 12%
Vomiting NOS 14% 6%
Anorexia, appetite decreased NOS, appetite disorder NOS 14% 3%
Diarrhea 13% 10%
Dizziness, syncope 13% 4%
Anxiety 12% 8%
Arthralgia, arthritis, joint stiffness 12% 5%
Abdominal pain 11% 8%
Injection site pruritus 10% 0%
Depression 8% 4%
Muscle cramps 8% 1%
Injection site ecchymosis 7% 5%
Back pain, back stiffness 6% 5%
Rash 6% 4%
Dry mouth 5% 4%
Somnolence, sedation 4% 1%

ISR=injection site reaction      NOS=not otherwise specified
Please see complete list of adverse events in the VIVITROL Prescribing Information.

DISCONTINUATION RATES

Discontinuation rate bar chart

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

In clinical trials, the majority of patients treated with VIVITROL experienced adverse reactions with a maximum intensity of "mild" or "moderate."

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. Review Medication Guide with your 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. Garbutt JC, Kranzler HR, O’Malley SS, et al. Efficacy and tolerability of long-acting injectable naltrexone for alcohol dependence: a randomized controlled trial. JAMA. 2005;293(13):1617-1625.
  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.