• E-mail
• Print
• Comment
• Font Size
• Digg
• del.icio.us
• Discuss article

Once-Monthly Injectable Drug a New Treatment for Alcoholism

Posted on: Tuesday, 13 June 2006, 21:00 CDT

PHILADELPHIA _ Alcoholics and people who drink too much now have a new option to try to quit: a once-monthly injection of a medicine that cuts the craving for alcohol.

The drug, Vivitrol, is an extended-release injectable form of naltrexone, which has long been sold as a daily pill.

Vivitrol, marketed by Cephalon Inc., of Frazer, works by blocking neurotransmitters in the brain believed to be associated with alcohol dependence, diminishing the craving for alcohol.

Developed by Alkermes Inc., of Cambridge, Mass., Vivitrol is approved by the Food and Drug Administration for adults who are able to abstain from drinking alcohol in an outpatient setting, and are not actively drinking when they begin treatment.

Researchers at the University of Pennsylvania, led by Joseph R. Volpicelli and Charles O'Brien, have studied naltrexone for more than two decades in suppressing cravings for alcohol and other substances, including opiates.

"I think it's fantastic," Volpicelli, a psychiatrist specializing in addictions, said about Vivitrol. "It's a very important, effective new tool for the treatment of alcoholism. It shows that using a medication can help."

"Naltrexone is particularly effective in people with a strong family history of alcoholism, or a pattern of binge drinking," Volpicelli said. "It's less effective in people who are still drinking when they get the first dose of medicine, and the daily consistent drinkers. And it's less efficient in women. For half of the alcoholics, it has a dramatic effect."

The once-a-month intramuscular Vivitrol shot will cost $695. The companies said they expect Vivitrol will be reimbursed as a medical benefit, rather than as a pharmaceutical.

Under their agreement, Alkermes and Cephalon, which is best-known for its narcolepsy drug, Provigil, will share profits from Vivitrol sales equally and will share responsibility for developing future commercial uses, possibly to treat other addictions.

The companies hope the monthly injections _ to be administered at a doctor's office, hospital or clinic _ will be an easier regimen for alcoholics than a daily pill. Treatment is supposed to include counseling or group therapy.

The advantage of Vivitrol is that a single shot provides medication over one month. "The ease of use for an addict is the best advantage," said David Rosenker, executive vice president of treatment for the Caron Treatment Centers, a well-known drug and alcohol addiction treatment center in Wernersville, Pa.

"One of the biggest things our patients experience when they leave treatment is cravings," Rosenker said. "To have a drug that addresses the cravings, for people returning to their home or their recovery environment, is wonderful."

The only way patients and physicians can learn where to get Vivitrol is by calling a toll-free number, 1-800-VIVITROL. Physicians can sign up to administer the injection treatments, and patients can learn locations in their area where the shots will be given. To date, more than 400 doctors have signed up to administer Vivitrol.

In combination with counseling, Vivitrol in studies showed a decrease in the number of days per month that people drank heavily. The most common side effects were nausea, vomiting, headache, dizziness, fatigue and injection site reactions.

Of the estimated 18 million Americans who abuse or are dependent on alcohol, about 2.2 million seek treatment each year, Cephalon said. More than 75 percent of these patients relapse and resume drinking within the first year of beginning treatment.

Treating alcoholism is more complex than just taking medicine, and experts caution the drug is not a one-shot cure. "This is not a magic bullet. It doesn't work alone," Caron's Rosenker said. "You need to use it in conjunction with therapy, counseling or outpatient services."

Vivitrol's price may keep some people from using it, but not "the population we see at Caron," Rosenker said. "We don't see that (price) as an issue."

The cost _ $695 for a 380-milligram shot _ surprised Wall Street analysts.

"It was higher than we thought, but I actually interpret that bullishly for the stock," said James Reddoch, biotech analyst at Friedman, Billings, Ramsey & Co. Reddoch raised his annual Vivitrol sales predictions based on the higher price.

"We are assuming that discussions with payors must have gone well," Reddoch wrote in a note, projecting 18,000 patients will take Vivitrol in the first year, for an average four months, amounting to $45 million in sales.

Reddoch projects Vivitrol sales will be $309 million in fiscal year 2011 and $361 million in fiscal year 2012. Sales of all prescription medicines to treat alcohol abuse _ three FDA-approved products _ was $40 million last year, up from $24.5 million in 2004.

Ian Sanderson, biotech analyst at Cowen & Co., said Vivitrol has been granted a J-code by the Centers for Medicare & Medicaid Services, which means the drug will receive Medicare coverage.

Because Vivitrol has Medicare approval, and will be administered in a physician's office, "it will be more difficult for health plans to push back and say patients have to fail on oral naltrexone first before going to Vivitrol," said Sanderson. Naltrexone pills cost $110 for a month's supply.

To sell the drug, Cephalon has a 120-person sales force focusing initially on 2,000 to 3,000 physicians who are addiction specialists and psychiatrists. Alkermes has 28 specialists to assist doctors with reimbursement, drug administration and patient compliance.

By adding Vivitrol to its product line, Cephalon hopes to bolster sales at a time investors are concerned that growth could slow. Under terms of a joint commercialization agreement, Cephalon paid Alkermes $160 million last June and another $110 million when the drug was approved by the FDA in April.

___

(c) 2006, The Philadelphia Inquirer.

Visit Philadelphia Online, the Inquirer's World Wide Web site, at http://www.philly.com/

Distributed by Knight Ridder/Tribune Information Services.

For reprints, email tmsreprints@permissionsgroup.com, call 800-374-7985 or 847-635-6550, send a fax to 847-635-6968, or write to The Permissions Group Inc., 1247 Milwaukee Ave., Suite 303, Glenview, IL 60025, USA.

Source: The Philadelphia Inquirer

More News in this Category