New drugs trying to carve out niche as treatments for alcoholism

Tuesday, September 13th 2005, 11:55 am

By: News On 6

BOSTON (AP) _ Above all else, John Bauhs credits a drug for helping him stop drinking _ a story line some alcoholics, doctors and drug companies hope will become more common as new treatment options emerge.

Bauhs tried practically everything he could think of to stop during 25 years of drinking but he couldn't stay sober until a year ago, when he began taking naltrexone _ a drug that can block the brain chemicals that make alcoholics feel good after a drink _ while also undergoing counseling.

``After being on the drug only three days, the urge to drink was completely gone,'' said Bauhs, a 41-year-old personal chef from Germantown, Md. ``The conscious thought not to drink doesn't even affect me anymore.''

Recovering alcoholics like Bauhs are winning allies among pharmaceutical companies and many doctors who want to include drugs alongside the old standbys of counseling and 12-step programs as standard treatments for alcohol abuse, despite initial reluctance by some health insurers to cover the newest drugs.

The medications have yet to become big sellers, but that could change. The first new such drug to win U.S. approval in nearly a decade hit the market in January, the third federally approved alcohol abuse drug. A fourth could be approved by year's end, with others in the pipeline.

Advances in studies on addiction and the brain also are driving a boom in research toward drugs to correct neurotransmitter imbalances among people prone to alcoholism, which has behavioral and biological components. The government's National Institute on Alcohol Abuse and Alcoholism is sponsoring more than 50 clinical trials involving drugs to treat alcoholism, compared with just six such trials a dozen years ago.

Among alcoholics who are treated, the vast majority aren't prescribed drugs _ experts say that's because most patients and few doctors other than addiction specialists are familiar with existing drugs, and most doctors consider alcoholism a largely behavioral problem best treated by counseling and programs like Alcoholics Anonymous. But traditional approaches through inpatient and outpatient programs have brought only mixed success, driving the push for new treatment options.

Just over a year ago the only federally approved alcohol abuse drugs were naltrexone, which won approval in 1994, and Antabuse, a decades-old drug designed to discourage drinking by making users sick if they have any alcohol.

``There was a long time when we groped around and weren't sure what we were doing in this field,'' said Robert Morse, a retired director of addiction treatment at Minnesota's Mayo Clinic now with the National Council on Alcoholism and Drug Dependence. ``But it should be an exciting field in the next decade.''

Because alcoholism can be traced to a complex set of mind and body triggers, doctors say the newer drugs are hardly cure-alls, and should be used in conjunction with counseling. And because the parts of the brain linked to alcohol dependence can range from those regulating stress to appetite, finding the right medication can be challenging.

Newer alcoholism medications ``can't solve alcoholism, but they can help some people,'' said Dr. Raye Litten, a treatment research leader at NIAAA. ``We want a menu of medications for alcoholism,'' he said, similar to the variety of depression treatments now available. ``If one doesn't work, they can try another one.''

The market potential is big. The NIAAA estimates about 18 million Americans are dependent on or abuse alcohol, with more than 2 million adults seeking treatment each year.

Despite those numbers, alcoholism drugs are small players in the $235 billion-a-year U.S. pharmaceutical industry. According to the consulting firm IMS Health, naltrexone and Antabuse posted less than $25 million in sales combined last year, with sales stagnant or declining in recent years.

Campral, which hit the U.S. market in January, recorded $6 million in sales through June, according to the drug's marketer, Forest Laboratories Inc. The company projects Campral sales will grow but never exceed $100 million a year.

Campral can help alcoholics remain sober by easing withdrawal symptoms and reversing drinking-induced imbalances in brain chemistry. The drug costs $3.70 for an average daily dose of six tablets.

Cambridge-based Alkermes Inc. expects to hear back from federal regulators by Sept. 30 on its application to begin marketing its new drug, Vivitrex, to doctors specializing in addiction medicine. In a clinical trial, the number of heavy drinking days per month among patients taking Vivitrex and undergoing counseling was reduced from an average 19 days to three over six months.

Vivitrex is a reformulation of naltrexone that is administered by monthly injection at a doctor's office, a potentially easier treatment option to follow for an alcoholic in recovery than a daily pill regimen.

Robert Hazlett, a drug industry analyst with SunTrust Robinson Humphrey, said emerging alcoholism treatments will only become commercial successes if more doctors consider prescribing them and insurers provide reimbursement.

``Even though there may be some good drugs available, it may take some time until they are more widely accepted,'' Hazlett said.

Many insurers include the older treatments Antabuse and naltrexone on their lists of preferred drugs, as well as coverage for inpatient and outpatient treatment. Reimbursement for the newer drug Campral varies from plan to plan, with some covering it and some not, said Larry Akey of America's Health Insurance Plans, a trade group for insurers.

Richard Pops, Alkermes' chief executive officer, expects insurers will eventually embrace his company's treatment and emerging rival drugs that he says will expand the market rather than take away from sales of existing medications.

``Alcoholism is so undertreated right now that there's room for a number of very important drugs,'' he said. ``I think it's the furthest thing from a zero-sum market I can imagine.''