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Injectable alcoholism drug wins FDA approval April 13, 2006 - msnbc.com
WASHINGTON - A once-a-month injection to treat alcoholism won federal approval Thursday, expanding availability of a drug previously sold only in daily pill form.
The Food and Drug Administration approved Vivitrol, spokeswoman Laura Alvey said. Cambridge, Mass.-based Alkermes Inc. will make the injectable form of the drug, also known as naltrexone. Cephalon Inc., of Frazer, Pa., will market and sell it.
The companies hope monthly injections of the drug, to be administered at a doctor?s office, will prove an easier regimen for alcoholics to follow than the daily pill. The drug is to be used in conjunction with counseling or group therapy, the companies said.
?Daily adherence to a medication is challenging for most people, and even more challenging for people with alcoholism,? said Richard Pops, Alkermes? chief executive officer.
The drug works by blocking neurotransmitters in the brain believed to be associated with alcohol dependence, diminishing the craving for alcohol.
Pops said the drug?s price wouldn?t be decided until its U.S. launch in late June. He didn?t offer sales predictions and said initial marketing would not include direct-to-consumer advertising.
Naltrexone initially won FDA approval for treating alcoholism in 1994. It first was sold to treat narcotic dependency. Other drugs to treat alcoholism include Antabuse, which has been sold since 1948.
The market for Antabuse and naltrexone has been limited, with annual sales in the low tens of millions of dollars.
Vivitrol will carry the strongest warning prescription drugs can bear. The black-box warning will caution patients that the drug can cause liver damage, said Dr. Elliot Ehrich, Alkermes? vice president. The pill form of the drug bears a similar warning, which says liver damage was observed at higher-than-recommended doses.
Frank Baldino, chairman and chief executive officer of Cephalon, said 2.2 million Americans are seeking treatment for alcoholism, among the 9 million who are alcohol-dependent.