>>...ALCOHOLISM. In contrast to the market for narcotic addiction therapies, Spectra Intelligence says the alcohol addiction medication market was just $125 million in 2005, but forecasts it to grow more than sixfold to $840 million by 2012. The small size today is despite a total potential market of 30 million or more people in the U.S., Europe, and Japan. Growth will come largely from the very recent launches of Vivitrol, developed by Alkermes and marketed by Cephalon, and of Campral, which has been gaining ground since FDA approved Forest Laboratories' version in 2004.
For about 45 years, the aversive agent disulfiram, sold by Odyssey Pharmaceuticals as Antabuse, was the only treatment. Today, some researchers consider it ineffective at best and often dangerous, as well as antiquated since it doesn't target known neurochemical mechanisms in alcohol addiction. Instead, it works by inhibiting aldehyde dehydrogenase, an enzyme that converts acetaldehyde to acetic acid, which leads to a buildup of acetaldehyde in the body. After taking disulfiram and then consuming alcohol, a person experiences nausea, flushing, headaches, and chest pains. The drug also can have more severe adverse effects, including death. Many patients simply stop taking it.
In 1994, an oral form of the opioid antagonist naltrexone, renamed ReVia, was approved by FDA for treating alcoholism; it is now sold as a generic drug under many different names. The drug's safety profile is good at lower doses, although it can cause liver failure at excessive doses and thus bears a warning on its label, which some in the field say has limited its use. It generally has been considered moderately effective in reducing drinking and cravings.
Alcohol dependence, with relapse rates of more than 75% after one year, and other addictions often require extended treatment and retreatment. Patient compliance is a serious issue with oral medications, according to David R. Gastfriend, Alkermes' vice president of medical affairs. "About 30 years ago, NIH issued a call for help to develop technologies for extended-release preparations," he says. With seed money from NIAAA and NIDA, Alkermes spent about six years developing Vivitrol, which was approved in April.
Vivitrol is naltrexone embedded in polymer microspheres for once-monthly intramuscular injection. Clinical studies have demonstrated that patients like the new formulation and can tolerate it and that its safety profile is good, he says. Results also show that Vivitrol helped decrease heavy drinking and prolong abstinence. In addition, the priming effect, which causes acute craving, is reduced. In clinical studies, patients used Vivitrol for at least six months, but in practice, a patient and physician will determine the duration of treatment.
FDA has approved Vivitrol for patients who have initiated abstinence, a group in which the drug has been found to work best and one consisting of individuals who essentially have chosen to address their dependence. It also is to be used in combination with psychosocial treatment. Although being abstinent or even entering treatment may be a hurdle, Gastfriend says, "the real message is that this is a potentially life-threatening disease, it's a medical condition, and it has to be taken seriously, and this is a serious medicine.
"We know that out of the 8 million or 9 million people in America with alcohol dependence, maybe 100,000 get medication, which is essentially nobody," he says, although about 2 million per year seek treatment. "Since 1935, at the outset of the Alcoholics Anonymous movement, we've had one major approach to treating alcohol dependence, and that is talking. And we have taken that, it seems, about as far as we are going to get with it," he says. He believes medications will be a crucial part of future treatment...<<
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