FDA Wants More Tests on Drug to Help Alcoholics

Ahighly 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.

In February, the FDA agreed to expedite its review of acamprosate, and in May an FDA advisory committee voted 8-2 to recommend approval of the drug.

Doctors and therapists are increasingly interested in using multiple treatment methods--including drug therapy--to help alcoholics, experts say.

Acamprosate, and an approved medication called naltrexone, in particular, address the physiological aspects of addiction and relapse.

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.

Merck KGaA officials said they have requested a meeting with the FDA to discuss the denial.

“We were very surprised here on that decision because the FDA’s own advisory committee voted, in the weeks before, strongly in favor of getting it to the market,” said Hartmut Vennen, a spokesman for Merck KGaA. “We don’t have any information that efficacy and safety could be a problem. So we are very curious to see what the [FDA’s] concerns are.”

Vennen said the company remains optimistic that it can bring the medication to the United States.

“We think that there is a high unmet need for such a drug,” he said. “It’s doing well here in Europe, and we have a lot of experience with it.”

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

Forest Laboratories holds the U.S. marketing and distribution rights for acamprosate, should it eventually reach the U.S. market.