Vivitrol On FDA Fast Track to Treat Heroin Addiction

Update:  Vivitrol was approved by the FDA for the treatment of opiate dependence on October 12, 2010.

Vivitrol is on the fast track for approval in the U.S. as a treatment for addiction to heroin, OxyContin and other prescription pain killers.  Here are some facts about Vivitrol:

  • Vivitrol is an extended release formula of the drug naltrexone
  • Vivitrol was approved for treatment of alcohol dependence in 2006
  • Vivitrol was granted priority review status as a treatment for opiate dependence by the U.S. Food and Drug Administration (FDA) in May, 2010
  • FDA is expected to make a decision on approval of Vivitrol as a treatment for opiate dependence in October, 2010
  • Vivitrol is non-narcotic, non-addictive, and a single dose lasts one month
  • Vivitrol is administered by injecting the medication into muscle

Unlike methadone or buprenorphine (brand names Suboxone and Subutex), Vivitrol is not an opiate replacement therapy.  Opiate replacement therapies treat compulsive use of fast acting opiates by prescribing therapeutic doses of longer acting, less euphoric opiates under medical supervision.

Naltrexone is not an opiate, but it has the ability to block the effects of opiates by physically occupying opiate receptor sites in the brain.

Naltrexone is already used to treat addiction to heroin or other pain killers, but usefulness of the treatment is limited by the fact that many patients simply skip doses or stop taking the medication as part of a relapse to opiate use.  A single dose of Vivitrol is active for one month limiting the temptation and opportunity to circumvent the treatment.

Methadone and Suboxone/Subutex (buprenorphine) also have medication adherence issues.  For example, many Suboxone patients in early recovery find it difficult to successfully hold their own medication and take the medication as prescribed.  Without adequate recovery supports, many patients relapse before they have a chance to establish a stable recovery.

A few concerns about Vivitrol:

  • Vivitrol patients must not have used heroin, OxyContin or other prescription pain killers within 7-10 days of taking Vivitrol (this complicates the process of getting an opiate dependent person started on the medication)
  • Patients who try to overcome the blockade effect of Vivitrol or who resume opiate use after discontinuing use of Vivitrol may be at increased risk for fatal drug overdose
  • Vivitrol, like other formulations of naltrexone, can be toxic to the liver (this may limit usefulness for some patients with active liver disease including some patients who became infected with Hepatitis C via injection drug use)

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