Heavy drinking days numbered

Alkermes, a biotechnology company from Cambridge, MA, US, has presented results from a Phase II clinical study that showed that patients treated with its once-monthly injections of Vivitrex, in combination with psychosocial therapy, experienced a 50% reduction in heavy drinking days compared with patients receiving placebo injections in combination with psychosocial therapy.

Vivitrex, an extended-release formulation of naltrexone using Alkermes' proprietary Medisorb technology, is currently being further evaluated in more than 600 patients in a Phase III study for the treatment of alcohol dependence.

In the multicentre, randomised, double-blind, placebo-controlled Phase II study, 30 patients were randomised to receive either Vivitrex 400 mg or a matching dose of placebo, administered intramuscularly once a month for four months.

After four treatment cycles, the mean percentage of heavy drinking days reported during the study was 11.7% in the Vivitrex-treated group versus 25.3% in the placebo-treated group.

'By definition, alcohol-dependent patients are difficult to treat and vulnerable to relapse, which is why it is encouraging to see how well patients responded to treatment in this study,' commented Dr Bankole Johnson, the study's lead investigator, and Wurzbach distinguished professor, departments of psychiatry and pharmacology, University of Texas Health Science Center at San Antonio. 'The once-monthly convenience of Vivitrex eliminates the need for daily treatment and encourages patient adherence, which ultimately may help them remain abstinent for longer periods of time.'

Phase III trial fully enrolled

Vivitrex is currently being studied in a Phase III multicentre, randomised, double blind, placebo-controlled clinical study at 24 US centres. The study completed enrollment of more than 600 patients in late March 2003, and initial results are expected in the first half of 2004. Following a six-month treatment period, patients can enter a 12-month extension study that will allow collection of long-term safety data.

'The rapid enrollment in the Phase III study reflects the need for new treatments that improve the lives of people with alcohol dependence,' stated Elliot Ehrich, M.D., vp - science and development and chief medical officer at Alkermes. 'We believe Vivitrex has the potential to fulfill that unmet need.'

In the U, it is estimated that 17m people suffer from alcohol dependency or meet diagnostic criteria for alcohol abuse disorder. More than half of all adult Americans have direct family experience with alcohol problems. Alcohol abuse is the cause of more than 100,000 deaths in America each year. According to a study by the National Institute on Alcohol Abuse and Alcoholism (NIAAA) and the National Institute on Drug Abuse (NIDA), in 1998, alcohol dependence and abuse cost Americans - private citizens, corporations, and federal, state and local governments - a total of $184.6bn.