FDA May Open Door to New Alcoholism Drugs

Federal regulators want to spur creation of more drug treatments for alcoholism, which affects roughly 17 million Americans but for which a new medication hasn’t been put on the market in nearly a decade.

The Food and Drug Administration has proposed relaxing its guidelines to allow new medicines to be sold if the drug makers can prove their products reduce alcohol consumption. The current guidelines require the drug makers to prove their product leads to total sobriety.

The change would make it easier for manufacturers to demonstrate to the FDA that their products are effective.

Currently there are two types of drugs to treat alcoholism: The first makes people sick whenever they take a drink, and the second reduces alcohol cravings. The drugs are usually given to patients who are on therapy and in self-help programs.

The options for the two types are very sparse. There is only one drug that makes alcoholics sick — disulfiram, known by the brand name Antabuse, which has been on the market since the 1950s. There are three drugs that reduce cravings, with the last one called naltrexone (brand name Vivitrol) being approved in 2006.