FDA REJECTS DRUG TO TREAT ADDICTION

A highly anticipated new drug to help recovering alcoholics remain
abstinent has been rejected by the Food and Drug Administration.

The agency turned down the application to market acamprosate, telling its
manufacturer, Merck KGaA of Germany, that the company had not adequately
demonstrated the medication's safety and efficacy. The FDA requested that
Merck KGaA conduct at least one more U.S. clinical trial.

Previous studies on acamprosate, which has long been used in Europe, showed
it to be free of serious side effects and modestly helpful in increasing
the chances of abstinence in motivated individuals.

Acamprosate was designed to treat the excessive stimulation of certain
neurotransmitters in the brain that sometimes occurs after alcohol
withdrawal. The increase in these brain chemicals causes insomnia,
irritability and agitation in some recovering drinkers, which can lead to
relapse.

Acamprosate would have been the first new medication for alcoholism in
seven years.