FDA has approved a new drug to treat alcoholism by taking it just once a month.
FDA has approved a new drug to treat alcoholism by taking it just once a month.
Alkermes Inc. and Cephalon Inc. launched the drug, Vivitrol, an injectable form of naltrexone administered monthly to help control cravings for alcohol.ReVia by Barr Pharmaceuticals Inc. is how the pill is sold generically.
This drug would be freely available by June end and in the form of a single dose, 380-milligram intramuscular injection.
Vivitrol was granted a conditional approval by FDA in December but said the companies had to provide more data before a final decision could be made, pushing final approval back by more than three months.
The deal is between two companies where the drug was developed by Alkermes, which will manufacture Vivitrol, while Cephalon takes on marketing and sales responsibilities.
The drug’s prescription would be in conjunction with therapy for patients who are able to abstain from drinking in an outpatient setting and are not actively drinking when initiating treatment. This was told by the companies.
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