Vivitrol: A Shot in the Dark
The Fix evaluates Vivitrol, the newest anti-addiction drug—actually an injectable form of an old pill. It's definitely better than nothing. But is it $1,100 a month better?
In a better world, alcoholics and addicts could control their addictions medically via a one-a-day pill or, better yet, a monthly shot. With no side effects, this magic bullet would remove the craving and compulsion to get high. Of course, the need to escape—“self-medicate”—the pain of living in your own skin would remain, but antidepressants, 12-step and other groups and therapy, if not sobriety itself, could go a long way to controlling that, too.
This hypothetical, er, cocktail of interventions—known as a “functional cure”—would make the disease of addiction manageable. The rate of recovery would jump from 20%, at best, to 90%.
It turns out that a pale version of this sci-fi medicine does exist. Called Vivitrol and made by Boston-based biotech Alkermes, it has been on the market for alcoholism since 2006 and for opiate addiction since 2010. It is not, however, a new drug. It is a new injectable formulation of an old drug called naltrexone, a once-a-day pill prescribed since the mid-‘90s for addiction. The newsiest thing about Vivitrol may be its price tag. While naltrexone, a generic, has an insurance copay averaging $11 a month, Vivitrol costs—deep breath!—about $1,100 a month. A growing number of health insurers are covering all or part of the bill. But still…
Vivitrol is no magic bullet. But like other drugs for alcoholism or heroin—starting with antabuse in the ‘50s and methadone in the ‘70s—the medical community has welcomed it as an additional tool in a skimpy arsenal. It is widely viewed as a significant advance over naltrexone because it appears to solve that one-a-day pill’s glaring drawback: the problem of compliance. Addicts had difficulty staying on it. Surrounded by environmental cues and hindered by bad habits, many people “forgot” to pop it. By contrast, Vivitrol, a monthly injectable (the needle is stuck in your butt), requires only a monthly doctor visit.
Some people in recovery swear by it. Wanda, a former opiate addict in her 40s, has been taking Vivitrol for 23 months. “My life is all for the better," she says. "It's expensive, but if you can find the money for the drugs, why can't you find the money for the shot?"
Others, not so much. William, a former alcoholic in his 50s, took naltrexone on and off over a period of years on his journey to sobriety. “It was hard to tell if naltrexone helped with cravings,” he says. “But any benefit was nowhere near big enough to be worth the price of Vivitrol.”
Neither Vivitrol nor naltrexone is a household word for addicts. Many doctors, when faced with a patient with a drinking problem, don't think to offer it as a treatment option. Likewise, this addiction medication often gets short shrift in rehabs and 12-step programs. But being a patient means advocating for yourself, so if you want to, you may have to demand to give this shot a shot.
The question is, weighing the costs and benefits, should you? Is it really effective? And if so, will it work for you?
Like all brain diseases, addiction is maddeningly complex and remains a black box for neuroscience. But Vivitrol/naltrexone works in a straightforward way: It blocks the brain’s opiate receptors, stopping opiate triggers like alcohol, heroin and painkillers such as Oxycontin. "Vivitrol curbs your enthusiasm for the drugs," says Timothy Fong, MD, director of the UCLA Addiction Clinic. "It diminishes your urges and cravings." It also blunts the pleasurable effects of intoxication.
Targeting opiate receptors is a daunting task, though, against substances as potent as alcohol and heroin, which set in motion a cascade of chemical reactions in the brain. There is evidence that Vivitrol works better against opiates than alcohol, however. The part of the opiate receptor targeted by Vivitrol is the same one that opiates attach to, allowing for a fairly complete blocking effect; against alcohol, which targets both that part and an additional one, Vivitrol is less powerful. “Alcohol is a promiscuous substance," says Erin Zerbo, MD, associate program director of the Addiction Psychiatry Fellowship at the NYU School of Medicine. "It affects many receptors in the brain."
“Everybody thought the FDA would be labeling around this major reduction in heavy drinking. People were surprised.”
The FDA looked favorably, if a bit peculiarly, on Vivitrol. Seven years ago, monthly Vivitrol injection won approval for alcohol dependence based in part on a six-month clinical trial: The 401 people on Vivitrol who completed the trial showed a 17% to 25% greater decrease in drinking days (no booze at all) and heavy drinking days (less booze) than those on placebo. But only 38 were abstinent. The rest decreased their alcohol consumption.
If fewer than 10% of those who got benefit from Vivitrol achieved abstinence, but 90% were able to moderate their drinking, the drug would appear to be most successful at—and best prescribed for—promoting controlled drinking, not abstinence. Yet the FDA slapped a label on Vivitrol saying that it is intended for patients who “are able to abstain from alcohol in an outpatient setting.”
“How did the FDA come to that conclusion?” Helen Pettinati, MD, a researcher in addiction at the University of Pennsylvania—one of the trial’s principal investigators—said to Boston Magazine. “Everybody thought they would be labeling around this…major reduction in heavy drinking. People were surprised.”
In its analysis, the agency also concluded that Vivitrol works in one in five people.
The FDA was even more enthusiastic about Vivitrol for opioid dependence, generally viewed as a more intractable disease than alcoholism. In a clinical trial of 250 Russian addicts (most also had hepatitis C, some had HIV and all were in desperate need of treatment), 90% of those on Vivitrol were abstinent for 19 weeks, compared to 36% of those on placebo. In addition to improving compliance, the drug had not only an anti-craving effect but what the FDA called an anti-relapse effect: People who “slipped” were better able to climb back on the wagon before falling into a bona-fide relapse.
The agency took note that Vivitrol has few downsides: There's no risk of abuse, addiction or overdose, meaning it has no street value. It does, however, have a few potential albeit rare side effects. Especially flagged is its liver toxicity—no surprise, since that organ is often compromised in opiate addicts with hepatitis C. (However, after getting reports of 51 deaths associated with Vivitrol between 2006 and 2010—an estimated 45,000 patients had by then received the drug—the FDA added black-box warnings to the label.)
The FDA also noted its unsuitability “for people who are philosophically opposed to agonist therapy (methadone or Suboxone) or patients whose employment prohibits agonist treatment, such as healthcare professionals, transportation workers, public safety officials and military personnel.”
Nora Volkow, MD, director of the National Institute on Drug Abuse (NIDA), lauded the approval: “Vivitrol obviates the daily need for patients to motivate themselves to stick to a treatment regimen—a formidable task, especially in the face of multiple triggers of craving and relapse.…NIDA is continuing to support research on Vivitrol's effectiveness."
But the FDA does not always get it right. In addition, the agency is often inclined to lower the bar for drug approvals when it comes to addiction, a serious disease with few treatments.
Oral naltrexone, having been around much longer than Vivitrol, has a track record that may raise some doubts. In 2010, the Cochrane Collaboration, the gold standard in independent reviews of drug studies, scrutinized all 50 available studies of naltrexone for alcoholism. Its conclusion? The drug did indeed help more patients reduce the amount and frequency of drinking than those who were on a placebo—at least for three months, which was the length of most of the studies. But Cochrane calculated that only one in nine people got these benefits.
- Timothy Fong
- UCLA Addiction Clinic
- Erin Zerbo
- Addiction Psychiatry Fellowship
- NYU School of Medicine
- Helen Pettinati
- University of Pennsylvania
- Nora Volkow
- National Institute on Drug Abuse
- Cochrane Collaboration
- Robert Woolhandler
- James Garbutt
- Alcohol and Substance Abuse Program
- UNC-Chapel Hill
- COMBINE study
- Raye Litten
- National Institute on Alcohol Abuse and Alcoholism
- Walter Armstrong