Alcohol DEPENDENCE DATA

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

PIVOTAL STUDY DATA1

  • 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 screening
    • Heavy drinking was defined as ≥5 standard drinks per day for men and ≥4 standard drinks per day for women
  • 627 outpatients were randomized to receive VIVITROL 380 mg (n=208), extended-release naltrexone (XR-NTX) 190 mg (n=210), or placebo (n=209)
  • Participants received an intramuscular injection every 4 weeks—a total of 6 injections over 24 weeks
    • Patients also received psychosocial support every other week

ALCOHOL STUDY DESIGN1

Alcohol study design

STUDY LIMITATIONS

  • The study was not designed to answer whether naltrexone may or may not work for women
    • The women who participated may not be representative of women with alcohol dependence in the general population, and the number of women studied was small
    • Men and women in this study differed on a number of important variables, including the prevalence of smoking and antidepressant use, weight, and commitment to abstinence
    • The men and women in this sample may have differed on other variables that may positively influence naltrexone response but were not assessed in this study, such as family history of alcoholism
  • Clinical trials may enroll patients with a greater degree of motivation for change than is seen among patients who are treated in traditional outpatient settings
  • Although treatment attendance was relatively high in this study, dropouts reduce the extent to which the findings generalize to all of those with alcohol dependence. Drinking data for dropouts were not obtained once they left the study, so it is not known how these drinking outcomes would have affected the results
  • Analyses of group central tendencies (median, mean) may not reflect the experience of individual patients

PRIMARY ENDPOINT: EVENT RATE OF HEAVY DRINKING1

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

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

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 (standard deviation [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

alcohol vivitrol heavy drinking chart

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 POPULATION: PATIENTS WHO ABSTAINED FROM DRINKING DURING THE 7 CONSECUTIVE DAYS PRIOR TO THE FIRST INJECTION1-3

A predefined subpopulation of lead-in abstinent VIVITROL, XR-NTX 190-mg, and placebo patients (n=53, or 8% of the total study population) was defined as those who reported no drinking during the 7 consecutive days prior to the first injection.

  • Due to the small numbers, this analysis should be interpreted with caution
  • The same treatment effects were not evident among the subset of patients (n=571, 92% of the total study population) who were actively drinking at the time of treatment initiation
  • Secondary data analysis; no adjustments were made for multiple comparisons
  • Only data for VIVITROL 380 mg and placebo are presented here

SUBSET POPULATION: PATIENTS TREATED WITH VIVITROL HAD GREATER REDUCTION IN THE NUMBER OF HEAVY DRINKING DAYS1-3

alcohol vivitrol subset population chart

SUBSET POPULATION: GREATER REDUCTION IN THE NUMBER OF ANY DRINKING DAYS1-3

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

0.2 drinking days
in the VIVITROL group:

Patients receiving VIVITROL with psychosocial support (n=17) had a median of 0.2 drinking days per average month

6.6 drinking days
in the placebo group:

Patients receiving placebo with psychosocial support (n=19) had a median of 6.6 drinking days per average month

  • At baseline, the median 7-day abstinent patient had 15.2 drinking days and 15.2 abstinent days per average month (30.4 days)

Psychosocial support was defined as bi-weekly counseling.


SUBSET POPULATION: COMPLETE ABSTINENCE FROM ALCOHOL1-3

SUBSET POPULATION: PATIENTS TREATED WITH VIVITROL WERE MORE LIKELY TO MAINTAIN COMPLETE ABSTINENCE THROUGHOUT TREATMENT1-3

A predefined subpopulation of lead-in abstinent VIVITROL, XR-NTX 190-mg, and placebo patients (n=53, or 8% of the total study population) was defined as those who reported no drinking during the 7 consecutive days prior to the first injection.

  • Due to the small numbers, this analysis should be interpreted with caution
  • The same treatment effects were not evident among the subset of patients (n=571, 92% of the total study population) who were actively drinking at the time of treatment initiation
  • Secondary data analysis; no adjustments were made for multiple comparisons
  • Only data for VIVITROL 380 mg and placebo are presented here

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

Percent of patients maintaining continuous abstinence bar chart

At baseline, the median 7-day abstinent patient had 15.2 drinking days and 15.2 abstinent days per average month (30.4 days).

Psychosocial support was defined as bi-weekly counseling.


ADVERSE REACTIONS IN
ALCOHOL-DEPENDENCE PIVOTAL TRIAL2

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%
Pharyngitis 11% 11%
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 the complete list of adverse events in the VIVITROL Prescribing Information.

DISCONTINUATION RATE1,2

Discontinuation rate bar chart

Discontinuation rates due to adverse events in controlled clinical trials of 6 months or less were similar in alcohol-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

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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]. Waltham, MA: Alkermes, Inc; rev March 2021.
  3. Data on file. Alkermes, Inc. Waltham, MA.

*Terms and Conditions

Eligibility for Alkermes-Sponsored Co-pay Savings. This offer is only available to patients 18 years or older, with a prescription consistent with the Prescribing Information and the patient is not enrolled in, or covered by, any local, state, federal or other government program that pays for any portion of medication costs, including but not limited to Medicare, including Medicare Part D or Medicare Advantage plans; Medicaid, including Medicaid Managed Care and Alternative Benefit Plans under the Affordable Care Act; Medigap; VA; DOD; TRICARE; or a residential correctional program.
Additional Terms of Use: This offer is not conditioned on any past, present, or future purchase, including refills. Alkermes reserves the right to rescind, revoke, or amend this offer, program eligibility, and requirements at any time without notice. This offer is limited to one per patient, may not be used with any other offer, is not transferable and may not be sold, purchased or traded, or offered for sale, purchase or trade. Void where prohibited by law. Program Administrator or its designee will have the right upon reasonable prior written notice, during normal business hours, and subject to applicable law, to audit compliance with this program.