Vivitrol?

By Todd Wallack

March 23, 2009

For years, Kyle was a slave to alcoholism. Every day after work, he returned to his Burlington home to down malt liquor and vodka, slowly surrendering relationships with friends and family. "It wasn't a life to live," said Kyle, 29, who asked that his last name not be used.

Finally, his parents intervened. After a month in rehabilitation, he moved into a group home for recovering alcoholics and started counseling. But Kyle also tried something different - a monthly injection of a drug called Vivitrol to reduce his craving for alcohol. He says he has been sober for about a year and gives much of the credit to his continued use of the treatment, made by Alkermes Inc., a Cambridge biotechnology company.

"I would absolutely recommend it [Vivitrol] to anyone who is looking to get sober," he said. "I would obsess about drinking all the time, and I just don't think about it anymore."

But when Kyle mentions the drug to other alcoholics, he mostly gets puzzled looks. "Nobody has any idea what it is," he said.

Despite a litany of similar testimonials about its effectiveness, Vivitrol has largely been a commercial flop. There are several reasons: Many alcohol treatment programs resist using drugs; some doctors contend Vivitrol doesn't work for most patients; and it's expensive - $800 a month.

According to the National Institute on Alcohol Abuse and Alcoholism, there are about 8 million alcoholics in the United States, yet only a few thousand use Vivitrol, nearly three years after it went on the market. Alkermes recently predicted it will generate no more than $24 million in sales for this fiscal year, far below initial expectations.

A major challenge facing Alkermes is that its novel approach runs counter to decades of tradition. Historically, alcohol treatment programs have relied more on counseling than medication. Many alcoholics turn to support groups, like Alcoholics Anonymous, rather than doctors, who have the authority to prescribe medications, and AA doesn't have an official opinion on Vivitrol or other drugs.

Larry Luttrell, owner of the Liberty House and Liberty Ranch addiction treatment centers in Los Angeles and Kentucky, called drugs like Vivitrol a "crutch."

"We want people to be drug free," said Luttrell, adding that 12-step programs are much more effective than medication. "You've got to face reality."

Alkermes said it recommends Vivitrol to supplement - not replace - counseling. But it also acknowledges it must change long-held ideas about treating alcoholism. "When you develop a new market, it takes time," said Jim Frates, the company's chief financial officer.

Over the past 60 years, drugmakers have marketed a handful of alcoholism treatments, none of which is widely used.

In the late 1940s, Danish researchers discovered Antabuse, which produces unpleasant side effects, such as nausea, when people ingest alcohol, discouraging them from drinking. But many patients stop taking the pill after they are discharged from treatment.

More recently, the FDA approved Campral, designed to help wean people off alcohol by reducing some withdrawal symptoms, such as insomnia and anxiety. But Campral needs to be taken three times a day, and showed mixed results in clinical trials.

Regulators also approved Naltrexone, which was thought to reduce cravings for alcohol by blocking certain neural receptors. But it must be taken daily, which means an alcoholic needs to decide against drinking every day. For many, that proved impossible.

So Alkermes set out to create a better version of Naltrexone, calling it Vivitrol. Through an injection, the drug slowly releases into the bloodstream over a month, making it less likely that alcoholics will skip a dose and resume drinking.

At least two studies underwritten by Alkermes have shown Vivitrol can help some patients. A 2005 report in the Journal of American Medicine found it reduced "heavy drinking days" by one-quarter when combined with counseling. A few months ago, researchers at the Behavioral Health Research Center of the Southwest in Albuquerque confirmed the drug reduced patients' drinking during a 24-week study, when combined with psychological support. Alkermes said it's up to doctors and patients to determine how long to continue taking the drug, but most kept using it after the six-month study was completed.

One of the drug's biggest supporters is Dr. Punyamurtula Kishore, who has prescribed it for hundreds of patients.

"Vivitrol has been an absolute champion in my clinic," said Kishore, medical director of Preventive Medicine Associates Inc., which operates three dozen offices across the state. "It's an awesome drug."

Kishore rattled off a list of patients he said have benefited from Vivitrol, including a nurse addicted to alcohol for years who has been sober for more than a year, and a teenage girl and physical therapist who have both kicked an addition to cocaine and alcohol.

Still, some doctors have not been impressed by Vivitrol studies. Dr. David Sack, chief executive of the Promises Treatment Centers in Malibu, Calif., said it works only for a small percentage of alcoholics. He prescribes it for patients who have intense cravings for alcohol even after weeks of therapy.

Other doctors shy away from Vivitrol for different reasons. Dr. Kim Dennis, medical director at the Timberline Knolls treatment center near Chicago, said the same mechanism that helps diminish the need for alcohol also dulls the natural highs of exercise, sex, or other activities. As a result, she prefers to prescribe a pill version of the drug - so patients can choose to skip a dose.

Also, she said many patients don't want to treat alcoholism with drugs, out of fear they will replace dependence on one substance with another, even though Dennis said Vivitrol isn't addictive. "The irony is that they are willing to take drugs that harm them, but they have all sorts of fear about drugs that might help them," she said.

And then there's the cost - about $9,600 a year. Even though many insurance companies officially cover its use, several doctors said they had trouble getting reimbursed. In some cases, insurers require them to try other treatments first. Insurance companies can also be fussy about the coding on the forms.

"We have had great difficulty getting reimbursed," said Paulene Yore-Brown, director of behavior health services for the Lowell Community Health Center. Yore-Brown said the center has had some success with Vivitrol, but rarely recommends it because of reimbursement complications and the price.

In addition, because Vivitrol is given by injection, patients can't fill a prescription for it at their neighborhood pharmacy. Instead, they usually receive an injection from a doctor or nurse.

Vivitrol's sales have been so disappointing that Cephalon Inc., which controlled the US marketing rights for Vivitrol, opted out of the deal in December, leaving Alkermes with sole responsibility for selling the drug domestically.

But Alkermes isn't giving up. The company said it is working to resolve reimbursement issues, improve Vivitrol's distribution, and better explain its benefits to addiction specialists. It is also testing Vivitrol to treat addictions to heroin and other opioid-based drugs, in a clinical trial. And another partner, Johnson & Johnson, is preparing to launch the drug in Russia.

"We wouldn't be excited about this opportunity if we didn't receive testimonial after testimonial saying how important this drug has been for them," said Frates, the Alkermes executive. "Literally, letters from patients saying, 'You saved my life.' We know the drug is working in patients. We just need to connect the dots."

ęCopyright 2009 Globe Newspaper Company.


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