DuPont Merck's ReVia Gains US Approval For Alcoholism

DuPont Merck's ReVia (formerly Trexan; naltrexone) has been approved for the treatment of alcoholism in the USA. It has already been available since 1984 for the treatment of narcotic dependence.

Approval of the new indication was based on two 12-week outpatient studies (together involving 186 patients). The first study (n=104) found that 50mg naltrexone daily was superior to placebo in maintaining abstention rates (51% versus 23%) and preventing relapse (31% versus 60%). The second study (n=82) demonstrated relapse rates of 21% for ReVia and 41% for placebo.

DuPont Merck is committed to carrying out Phase IV studies on an escalating basis, dependent on the number of prescriptions issued for this indication in a year. For low rates of usage (less than 200,000/year), no Phase IV studies are required, but above this level and stepwise thereafter trials in a number of patient populations, eg those with renal and hepatic impairment, those taking concomitant medications, pregnant alcoholics and adolescent patients, are required.