Vivitrol (naltrexone for extended-release injectable suspension)

The following drug information is obtained from various newswires, published medical journal articles, and medical conference presentations.

Company: Alkermes
Approval Status: Approved April 2006
Treatment Area: alcohol dependence

General Information

Vivitrol is an extended-release injectable suspension formulation of naltrexone. Naltrexone is an opioid antagonist with highest affinity for the mu opioid receptor. Naltrexone has little or no opioid agonist activity.

Vivitrol is specifically indicated for the treatment of alcohol dependence in patients who are able to abstain from alcohol in an outpatient setting prior to initiation of treatment with Vitvitrol. Patients should not be actively drinking at the time of initial Vivitrol administration.

Vivitrol is supplied as a liquid suspension for intramuscular injection. The recommended initial dose is 380 mg delivered intramuscularly every 4 weeks (once a month).

Clinical Results

FDA Approval
The FDA approval of Vivitrol for alcohol dependence was based on a 24 week, placebo-controlled, multi-center, double-blind, randomized trial. Subjects were treated with an injection every 4 weeks of Vivitrol 190 mg, 380 mg or placebo. Subjects treated with Vivitrol 380 mg demonstrated a greater reduction in days of heavy drinking than those treated with placebo. Heavy drinking was defined as self-report of 5 or more standard drinks consumed on a given day for males and 4 or more drinks for females. Among the subset of patients (n=53, 8% of the total study population) who abstained completely from drinking during the week prior to the first dose of medication, those treated with Vivitrol 380 mg had greater reductions in the number of drinking days and the number of heavy drinking days compared with placebo-treated patients. In this subset, patients treated with Vivitrol were also more likely than placebo-treated patients to maintain complete abstinence throughout treatment. 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.

Side Effects

Adverse events associated with the use of Vivitrol may include, but are not limited to, the following:

nausea
vomiting
injection site reactions
muscle cramps
dizziness
somnolence
anorexia, decreased appetite or other appetite disorders

Mechanism of Action

Literature References

Mannelli P, Peindl K, Masand PS, Patkar AA Long-acting injectable naltrexone for the treatment of alcohol dependence. Expert Review of Neurotherapeutics 2007 Oct;7(10):1265-77

Additional Information

For additional information regarding Vivitrol or alcohol dependence, please visit the Vivitrol web page.

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