Alcohol addiction drug may help opioid addicts: FDA panel considers reports

By Dr. Ananya Mandal, MDSep 17 2010

A U.S. Food and Drugs Administration (FDA) panel, this Thursday agreed that a new drug Vivitrol helps alcoholics and opioid addicts kick the habit. The panel voted 11 to 2 that there was sufficient evidence from a single clinical trial that Vivitrol is effective when it comes to helping people addicted to painkillers.

Vivitrol is a new formulation of naltrexone, which has been used for years in an oral form and is available as a generic. Side effects of Vivitrol can include infections, sleep problems and injection site reactions.

Vivitrol is a once-monthly injection that was approved in 2006 to treat alcohol dependency. The drug was never really used widely for this indication because it was expensive. Researchers from the pharmaceutical company that made this drug, Alkermes also noticed it also helped prevent people who had recently got over their opioid addiction from relapsing.

Vivitrol's net sales were $20.2 million for fiscal 2010 because of its cost. Sales could reach $125 million by 2015 if the drug wins wider approval, according to Leerink Swann Research Analyst Steve Yoo.

According to panelist Betty Tai, director of the Center for Clinical Trials Network at the National Institute on Drug Abuse at the National Institutes of Health, “We do need tools…We do need options, and we have so few options for addiction.” Panelist Louis Baxter, a New Jersey physician said, “We need to understand this is an adjunct… There's no one drug that can be a magic bullet.”

Alkermes Chief Executive Richard Pops feels that this FDA panel's support was “such an important milestone.” He added that take up among opioid addicts should be better since many see doctors while most alcoholics rely on counseling and other programs.

Panel members who opposed the drug were concerned that the company's bid hinged on just one clinical trial done in Russia.

Approval from the FDA is not yet certain. The FDA does not have to follow the recommendations of its panels, but it typically does. FDA officials will consider the panel's recommendation as they are expected to make their final approval decision, by October 12.