FDA OKs New Alcoholism Treatment
Once-Monthly Injectable Drug, Called Vivitrol, to Launch in June
Abstaining From Alcohol
Participants were asked to abstain from alcohol for a week before the first shots were given. "They were not required to abstain prior to starting treatment," Bohn says. "Some selected to, and others did not."
Those who abstained from alcohol for at least four days before their first Vivitrol shot "did even better," Bohn says. Those participants were "significantly more likely to remain abstinent, and they had a significant reduction in the rate at which they drank heavily if they did not abstain," Bohn says.
"So there were benefits both for those who were able to abstain altogether ... and even among those who did not abstain, they were much less likely to drink heavily," Bohn says.
How It Works
"We think that the medication works by binding to opioid receptors in the brain," Bohn says.
"We don't know exactly how opioid receptors are involved in alcohol dependence, but there's very good preclinical data that indicate that medications that bind to these receptors and block them reduce drinking and remove the incentive to drink," he explains.
About 18 million people in the U.S. are dependent upon alcohol or abuse alcohol, and more than 2 million of those people receive treatment each year, Bohn notes. He says Vivitrol offers "a new hope to a really significant number of them."
A once-per-month treatment could enhance compliance with medication, Bohn says, calling Vivitrol "a really significant advance to clinicians who are treating patients who want to stop their drinking."
Alkermes and Cephalon state that Vivitrol's active ingredient, naltrexone, may cause liver damage when given in excessive doses and that the drug shouldn't be taken by patients using opioid drugs or those in acute opioid withdrawal.
Vivitrol was "generally well tolerated" in clinical trials, the companies state, reporting mild to moderate side effects with the drug. In clinical trials, Vivitrol's most common side effects were nausea, vomiting, headache, dizziness, fatigue, and reactions at the injection site, according to the news release.
Participants who completed the Vivitrol study were allowed to keep taking Vivitrol (or switch to it, if they had previously taken the placebo); 85% accepted that offer, Bohn says.
"What this is says is that the acceptance rate for people who are on this medication is quite high," Bohn says. "Because there were relatively few side effects and the medication was well-tolerated, and because people liked coming in to get an injection, this type of treatment with Vivitrol offers a really exciting new opportunity, as far as I'm concerned."