A 24-week, multicenter, double-blind, randomized, placebo-controlled trial1,2
PIVOTAL STUDY DATA
-
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
*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
§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
§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
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
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 rates due to adverse events 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.
