Extension study
A 1-year, open-label extension phase of the initial 24-week, double-blind study of vivitrol in opioid-dependent (DSM-IV) outpatients, ≥18 years of age1
Extension study design1
A 1-year, open-label extension phase of the initial 24-week, double-blind study of VIVITROL in opioid-dependent (DSM-IV) outpatients aged ≥18 years intended to assess safety as well as the durability of effect.
All patients treated with VIVITROL or placebo who completed the initial 6-month study were eligible for this extension study.
Patients received VIVITROL every 4 weeks for up to 13 doses (a total of 19 VIVITROL injections over 18 months for patients who received VIVITROL in the initial study).
Counseling, efficacy assessments (including UDTs and opioid craving), and safety assessments were performed monthly.
Although the extension trial reported on safety and efficacy results, it was only powered to assess safety.
Of the patients who completed the 1-year extension trial
Study limitations1
- Long-term efficacy of VIVITROL with individual drug counseling was based on open-label treatment, without randomization
- Patients who sought to enter the open-label extension study may have represented a subgroup with higher motivation, resulting in more favorable outcomes once switched to active VIVITROL during the open-label phase
- The generalizability of this study might be limited because it was conducted in Russia
- Patients were not tracked after dropout from treatment in either the 24-week trial or the 1-year extension
Adverse reactions in 1-year, long-term extension trial of vivitrol1
| number of patients (%) | |||
|---|---|---|---|
| Events | Overall(n=114) | VIVITROL ➝ VIVITROL(n=67) | Placebo ➝ VIVITROL(n=47) |
| Any adverse event | 48 (42.1%) | 29 (43.3%) | 19 (40.4%) |
| Discontinued owing to non-serious adverse event |
1 | 0 | 1 (2.1%) |
| Toothache | 7 (6.1%) | 3 (4.5%) | 4 (8.5%) |
| Influenza | 6 (5.3%) | 4 (6.0%) | 2 (4.3%) |
| Bacteriuria | 3 (2.6%) | 2 (3.0%) | 1 (2.1%) |
| Injection site pain | 3 (2.6%) | 1 (1.5%) | 2 (4.3%) |
| Deaths | 0 | 0 | 0 |
| Serious adverse events | 3 (2.6%) | 3 (4.5%) | 0 |
| Study drug–related adverse events* |
24 (21.1%) | 14 (20.9%) | 10 (21.3%) |
- 3 patients experienced a total of 4 serious adverse events: acute pancreatitis (judged possibly related to treatment), cardiomyopathy, hepatitis A, and pulmonary tuberculosis (the latter 2 occurring in the same patient)1
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.
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REPRESENTATIVE
Request a visit from a VIVITROL representative to learn more about how VIVITROL may help your appropriate patients with opioid dependence or alcohol dependence.
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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.
LEARN MOREReferences: 1. Krupitsky E, Nunes EV, Ling W, Gastfriend DR, Memisoglu A, Silverman BL. Injectable extended-release naltrexone (XR-NTX) for opioid dependence: long-term safety and effectiveness. Addiction. 2013;108(9):1628-1637. 2. VIVITROL [prescribing information]. Waltham, MA: Alkermes, Inc; rev March 2021.
†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.