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The Physiological Frontier
May 2006

In 2002, The World Health Organization identified alcoholism as the third leading risk to health in the developed world, and the leading risk in low mortality developing countries like Russia. When WHO data on tobacco and illicit drugs are thrown into the mix, substance abuse emerges as probably the leading cause of death and disability worldwide, substantially beating out other single causes like high cholesterol, unsafe sex, obesity and diet deficiencies.

And yet, despite the overwhelming evidence of addiction's role as a key underlying cause of myriad types of death, not to mention disability and productivity lost, the resources devoted to treating addiction within healthcare systems continues to be pitiful, representing a tiny fraction of total expenditures. In the U.S., where annual spending on healthcare is approaching $2 trillion, probably only about $15 billion at most is spent directly on addiction treatment, with substance abuse treatment providers representing less than 1 percent of the total healthcare industry.


And so, too, has it been with drug developers and pharmaceutical companies, who over the past decades have also paid scant attention to addiction, despite the growing evidence of its pervasiveness in the etiology of disease, as well as its ever mounting cost to society. But all that has started to change, albeit relatively slowly, in the last ten years or so. In fact, so much more research is currently being undertaken, both at the basic scientific level and at the commercial level, that many are beginning to talk about how the addiction treatment industry may be on the cusp of a revolution, one that could be led by advancements in addiction pharmacotherapies.

Revolution

"We believe that addiction treatment is in the very early stages of a revolution, one that is very similar to the revolution in the treatment of many psychiatric disorders that came with the introduction of the selective serotonin reuptake inhibitors like Prozac and other drugs in the 1980s," says Tony LaMacchia, COO of Los Angeles-based Hythiam Inc. Over the last couple of years, Hythiam has raised more than $80 million on Wall Street for development, clinical testing and marketing of its Prometa Protocol, which the company believes is highly effective in reducing craving and improving cognitive functions for those in treatment for addiction to alcohol, and stimulants like cocaine and methamphetamine.

Other companies also see plenty of opportunity. Drug developer Alkermes and pharmaceutical marketing powerhouse Cephalon have recently turned their attention to the addiction problem, together launching a newly approved long lasting naltrexone injection called Vivitrol. "The environment right now very much reminds us of depression a couple of decades ago, and the subsequent revolution in the treatment of that affliction that came with the introduction of new pharmacological treatments," says Alkermes CEO Richard Pops, adding that Alkermes is currently examining a number of different avenues for development of possible new drug treatments for addiction. Saying that one day Vivitrol could have annual sales of as much as $500 million, Frank Baldino Jr., CEO of Cephalon, also sees big opportunities with drug treatments for addiction.

Burst of Activity

And Alkermes and Cephalon are far from alone. There are currently 35 addiction drugs in various stages of development and clinical trials throughout the world. As only a handful of drugs have ever been approved for addiction, this represents the largest burst of activity with respect to addiction ever underwritten by commercial drug companies. And the level of basic research being undertaken by government agencies, universities and private non-profit institutes has also increased substantially, with, for example, the National Institute on Alcohol Abuse and Alcoholism currently running more than 50 trials using drugs and plant extracts.

"Tremendous strides are being made in the development of new drug treatments for addictions based on a greater understanding of the neurobiological pathways of addiction and pharmaceutical innovation," says Tim Atkinson, principal at Spectra Intelligence, a biotech and pharmaceutical research house based in London. "Novel drugs with unique therapeutic approaches and long-acting reformulations to combat physical and psychological dependencies will revolutionize addiction pharmacotherapy interventions over the next 7 years."

Most addiction drugs currently in the commercial pipeline, and indeed much of the basic research being done, concentrate on the role neurotransmitter systems involved in the brain"s pleasure/reward pathways play in addiction. But other approaches are also beginning to be taken, including pioneering work being done by basic researchers like the Scripps Research Institute"s Dr. George Koob, who recently spoke at a the Hanley Center"s Aging and Addiction conference about the work he is doing examining what role the neurobiology of stress might have in contributing to addiction.

Despite the recent flurry of activity by drug companies, addiction drugs remain a tiny pharmaceutical niche, accounting in 2005 for just over $2 billion of the industry"s overall audited global sales of $525 billion, according to Spectra Intelligence. And Spectra expects sales of addiction pharmacotherapies to grow by over 40 percent to almost $3 billion by 2012, with sales potentially reaching $5 billion by the year 2020.

But even with the substantial growth rates forecast for addiction pharmaceuticals, the category will remain small by comparison to other medications. The market for blood pressure pharmaceuticals in the U.S. alone accounts for over $16 billion in sales, while the market for cancer drugs worldwide is expected to top $40 billion by 2008.

The irony of this, because of addiction"s key role in the etiology of so many diseases, is hard to underemphasize. Alcoholism is considered a leading cause of high blood pressure, but the amount of money spent developing drugs to combat alcoholism is an infinitesimal fraction of that spent on drugs to fight high-blood pressure itself.

And it is certainly a pipe dream that the resources devoted to addiction drug development could ever approach those devoted to something like cancer, which in 2005 accounted for some 30 percent of global pharmaceutical R&D expenditures. Yet, according to the WHO, addiction is considered a primary cause of a large number cancers, including, of course, lung cancer, but also esophageal cancer, and, to a lesser degree, cancers of the breast, liver, colon and others. The list goes on, with addiction playing a determining role in a vast number of afflictions on which billions of dollars are spent every year for medications, and on which further every year for medications, and on which further billions are spent developing new medications, with very little being spent on one of disease's primary etiological factors, which is addiction itself.

The Big Players

Nevertheless, some of the world's very largest pharmaceutical players like Sanofi Aventis, Bristol-Myers Squibb and GlaxoSmithKline are taking a shot at coming to market with drugs that treat addiction. Most of these big companies, however, are looking to see if drugs that have already been approved to treat other diseases can also be used to treat addiction disorders as well, a process that potentially involves some considerable expense in clinical trials and testing, but which is a far cry from the kind of money and effort it takes to develop a drug from scratch.

For example, Bristol-Myers is working to find out if its Abilify drug (aripiprazole), which works on the dopamine system in the brain and is currently approved for the treatment of schizophrenia, can also be used to treat cocaine addiction. And Ortho-McNeil Neurologics, a unit of giant Johnson & Johnson, is studying to find out whether or not its migraine and epilepsy drug Topamax (topiramate) is effective in reducing alcoholic cravings.


Some of the more interesting work on addiction is being done by small drug development specialists, one of which is examining the effectiveness of pharmacotherapies to treat gambling addiction, as well as potentially other disorders like sex addiction and compulsive shopping. In late 2004, San Diego-based Somaxon Pharmaceuticals, which raised $55 million in an IPO last December, acquired the North American rights to a drug called oral nalmefene hydrochloride from BioTie Therapies of Finland. BioTie is currently in Phase III trials for nalmefene, which is an opioid receptor antagonist, to treat alcohol addiction. Somaxon hopes to use nalmefene's pharmacological properties in preventing neurochemical reward reinforcement to reduce compulsions to gamble, and with other compulsions as well.

The company is currently in the Phase II/III clinical trial stage in testing nalmefene for gambling, in February releasing results of a double-blind placebo study conducted by Dr. Jon Grant of the University of Minnesota. The trial, which tested 207 pathological gamblers at multiple locations, found a "statistically significant reduction in the severity of pathological gambling."

If Somaxon is successful in getting its nalmefene gambling addiction treatment approved by the FDA, Spectra Intelligence believes the company will pioneer a new subsector of the addiction pharmacotherapy market for compulsive behavior addictions, one that could be worth as much as $400 million annually by 2012.

Certainly, the numbers appear to reinforce Spectra's optimism about the potential market for gambling. Backed by the explosive growth in Internet casinos and the rapid spread of legalized wagering outside of Nevada, gambling has become, after methamphetamine, probably the fastest growing type of addiction in the United States. TJ

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