Magazine article Clinical Psychiatry News

Naltrexone Is Safe but Needs Stronger Label, Panel Advises

Magazine article Clinical Psychiatry News

Naltrexone Is Safe but Needs Stronger Label, Panel Advises

Article excerpt

Naltrexone is safe and effective for the treatment of opioid abuse, but the company should build on existing labeling that calls for monitoring and support as essential parts of therapy, a Food and Drug Administration advisory panel said.

Lingering concerns about the applicability of the results from the single clinical trial, which was conducted in Russia, to the U.S. population were not enough to stem the tide of support. The Psychopharmacologic Drugs Advisory Committee voted 11-2 with no abstentions in middle September that data from the trial were sufficient to demonstrate efficacy, 10-1 with 2 abstentions that the data could be applied to the U.S. population, 12-0 with 1 abstention that the safety data were adequate, and 12-1 that the supplemental indication should be approved.

Alkermes Inc., maker of naltrexone under the name Vivitrol, has a head start on the monitoring and support question from the drug's current label for alcohol abuse treatment, which states: "Alcohol-dependent patients, including those taking Vivitrol, should be monitored for the development of depression or suicidal thinking. Families and caregivers of patients being treated with Vivitrol should be alerted to the need to monitor patients for the emergence of symptoms of depression or suicidality, and to report such symptoms to the patient's health care provider."

The label also says that "patients should be advised that Vivitrol has been shown to treat alcohol dependence only when used as part of a treatment program that includes counseling and support."

Citing a presentation delivered on behalf of Alkermes by Dr. Paul Earley, medical director of the Talbott Recovery Campus, panel member Chung-yui Betty Tai, Ph.D., of the National Institute on Drug Abuse, said that Vivitrol "is a good medication for young [patients with a] short addiction history [who are] highly motivated, such as addicted professionals, and also with strong social and family support. Based on those, I think that's comparable to the Russian population in the study, based on the report I have reviewed."

"I am of the belief that no one piece of treatment decides totally what the outcome is," Louis Baxter, executive medical director of the Professional Assistance Program of New Jersey, said. …

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