Patients met the DSM-IV criteria for 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.
A total of 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 (IM) injection every 4 weeks in an outpatient setting for a total of 6 injections over 24 weeks, along with psychosocial support every other week. A total of 208 patients were randomized to the VIVITROL 380 mg group. Three patients did not receive any treatment due to enrollment failures based on investigator decision, leaving 205 patients included in the primary analysis and safety evaluation for the VIVITROL 380 mg group. Only data for VIVITROL 380 mg and placebo are presented here.
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.
*17 patients abstained 7 days prior to treatment. †19 patients abstained 7 days prior to treatment.Demographics and clinical baseline characteristics2
|
VIVITROL 380 mg (n=205)‡ |
Placebo (n=209) |
|
|---|---|---|
| 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 ≥20 hours/week | 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) |
Heavy drinking days were significantly reduced for patients treated with VIVITROL and counseling vs placebo2
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.2
FEWER HEAVY DRINKING DAYS PER MONTH VS PLACEBO
VIVITROL 380 mg (n=205) vs placebo (n=209; HR=0.75
[0.60-0.94]; P=0.02).
In a subset|| of patients able to abstain from drinking alcohol completely during the 7 days prior to initiation of outpatient therapy, a reduction in the number of drinking days and heavy drinking days was observed vs placebo1
Patients should not be actively drinking at the time of initial VIVITROL administration.1
Median heavy drinking days: ≥7-day abstinent subset (n=53) over 6 months1,3
Greater reduction in the number of any drinking days in a subset|| of patients who abstained from drinking 1 week before treatment1
Median any drinking days per month: ≥7-day abstinent subset (n=53)1,3
At baseline, the median 7-day abstinent patient had 15.2 drinking days and 15.2 abstinent days per average month (30.4 days).
||A predefined subpopulation of lead-in abstinent patients (n=53, or 8% of the total study population), defined as those who reported no drinking during the 7 consecutive days prior to the first injection.1 ¶Psychosocial support was defined as biweekly counseling.1Patients maintaining complete abstinence (%): ≥7-day abstinent subset (n=53)2,3
A greater proportion of patients with a 7-day lead-in abstinence on VIVITROL maintained abstinence throughout the 6-month study period vs those on placebo.1
#Psychosocial support was defined as bi-weekly counseling.1Treatment-emergent adverse reactions that occurred in ≥5% of patients with alcohol dependence treated with VIVITROL and that occurred more frequently in the VIVITROL group vs the placebo group1
|
VIVITROL 380 mg (n=205) |
Placebo (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% |
Please see the complete list of adverse reactions in the VIVITROL Prescribing Information.
ISR=injection site reaction; NOS=not otherwise specified.
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. Strongly consider prescribing naloxone for the emergency treatment of opioid overdose. See Important Safety Information below. See Prescribing Information. Review Medication Guide with your patients.
Request a visit from a VIVITROL representative to learn more about how VIVITROL may help your appropriate patients with opioid dependence or alcohol dependence.
REQUEST A REPRESENTATIVE
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:
**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.
