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Home | Clinical Trials

FDA Approved Drugs » 2010
Medical Areas: Neurology | Psychiatry/Psychology | Family Medicine

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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 October 2010
Treatment Area: opioid 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 prevention of relapse to opioid dependence, following opioid detoxification.

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 opoid dependence was based on a 24 week, placebo-controlled, multi-center, double-blind, randomized trial of opioid-dependent (DSM-IV) outpatients, who were completing or had recently completed detoxification. Subjects were treated with an injection every 4 weeks of Vivirol 380 mg or placebo. Oral naltrexone was not administered prior to the initial or subsequent injections of study medication. The cumulative percentage of subjects achieving each observed percentage of opioid-free weeks was greater in the Vivitrol group compared to the placebo group. Complete abstinence (opioid-free at all weekly visits) was sustained by 36% of subjects in the Vivitrol group compared with 23% of subjects in the placebo group from Week 5 to Week 24.

Side Effects

Adverse events associated with the use of Vivitrol for opioid dependence may include, but is not limited to, the following:

  • hepatic enzyme abnormalities
  • injection site pain
  • nasopharyngitis
  • insomnia
  • toothache

Mechanism of Action

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.

Additional Information

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


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