Monthly injection new in the fight for sobriety

June 5, 2006

For a condition where compliance can be a big issue, a newonce-monthly injection will soon be available to help alcoholicskick the habit. In April, the Food & Drug Administrationapproved Vivitrol (naltrexone for extended-release injectablesuspension), a new treatment option from Alkermes and Cephalon.Vivitrol is indicated for alcohol-dependent patients who are ableto abstain from drinking in an outpatient setting and are notactively drinking at the beginning of treatment.

An advantage to a once-monthly form of treatment would be increased compliance, said Brian Fingerson, R.Ph., of the Kentucky Professionals Recovery Network in Louisville, "especially if the injections are being given by an addictions specialist who is helping in the monitoring of the patient's recovery."

In clinical trials, recipients of the Vivitrol injection showed a greater reduction in days of heavy drinking compared with those receiving placebo. "In a subset group of patients who did not drink for one week prior to the first injection, we were able to demonstrate complete abstinence for the six-month treatment period," said Elliot W. Ehrich, M.D., Alkermes' chief medical officer, at a press conference announcing Vivitrol's approval. The results showed a greater positive response in patients not actively drinking at initial Vivitrol administration, a recommendation that is now included as part of the prescribing information.

Ehrich went on to explain that, like oral naltrexone, Vivitrol will carry a black box warning about hepatotoxicity. The black box states that the drug has the capacity to cause hepatocellular injury when given in excessive doses and is contraindicated in acute hepatitis or liver failure. Ehrich explained, however, that "it does not appear to be a liver toxin at recommended doses."

The opioid blockade caused by naltrexone is surmountable, and therefore patients should be warned of the potential dangers of attempting to overcome the blockade by administering large doses of exogenous opioids-a situation in which patients would be at risk of life-threatening opioid intoxication.

"It would be very difficult to use an opiate on a patient for a legitimate medical reason with this long-acting form of naltrexone," said Fingerson of Vivitrol. Although the oral form of the drug has similar problems, he said, "I have a client who is being tapered from daily oral naltrexone prior to surgery on a brain tumor. This is being coordinated with her addictions specialist and the surgeon."

Frank Voltino Jr., Ph.D., chairman and CEO of Cephalon, said the company will begin educating 2,000 to 3,000 alcohol-dependence providers on the proper use of the injection. In addition, the company said it will roll out a new support program, called VIP-3, targeting the patient, physician, and payer. The company further said it expects Vivitrol to be covered by insurers as a medical benefit and will not release the cost of Vivitrol until launch, which will likely be sometime this month.

TIPS TO REMEMBER Vivitrol