FDA Approves Monthly Injection for Alcohol Dependence - CME Teaching Brief - MedPage Today
AMBRIDGE, Mass., April 13 - The FDA has approved a monthly injectable formulation of Vivitrol (naltrexone for extended-release) for treatment of alcohol-dependent patients, the drug marketers, Alkermes and Cephalon, announced today.
The drug, intended for use by outpatients who are not actively drinking, should be used in combination with psychosocial support, the announcement said.
The companies said they will market the drug in 380 mg IM doses and expect the product to be available by June.
"Vivitrol is the first once-a-month medication for alcohol dependence that ensures patients get the benefit of medication over the entire month," said Richard Rosenthal, M.D., chairman, of psychiatry at St. Luke's-Roosevelt Hospital Center in New York, in the companies' statement.
Vivitrol binds opioid receptors in the brain and preclinical data suggest that binding results in blockade of neurotransmitters that promote alcohol dependence. That blockade is thought to be the mechanism by which Vivitrol reduces alcohol consumption in treated patients.
Posted by gruwell at April 14, 2006 9:14 AM | TrackBack