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REVIA (naltrexone) licensed for treatment of alcohol dependence.

4 February 1999

REVIA (naltrexone), an opioid antagonist, is the first drug to be licensed in Australia for the treatment of alcohol dependence in 50 years. REVIA is indicated for use within a comprehensive treatment program for alcohol dependence.

REVIA is also indicated for use as adjunctive therapy in the maintenance of formerly opioid-dependent patients, but not for use in rapid detoxification.

REVIA is thought to reduce an individuals craving for alcohol by acting on the neurochemical pathways in the brain and blocking these opioids. Although the exact mechanism of action in alcoholism is unknown, data suggests that the body's opioid system may be involved. The body's own opioids are released in the brain when alcohol is consumed.

In a combined analysis of two 12-week clinical trials, evaluating the effectiveness of REVIA, patients who received REVIA were nearly twice as successful in avoiding relapse and significantly more successful in remaining abstinent than patients who received placebo.¹

REVIA is taken as a 50mg tablet once daily. Shortly after the first dose, REVIA's effects on blocking the craving for alcohol occur. If REVIA is tolerated and the patient is successful in reducing or stopping drinking, the recommended course of treatment is for 3 months.

In a clinical safety study of REVIA, with approximately 570 individuals, the following side effects occurred in two per cent or more of those treated: nausea (10%), headache (7%), dizziness (4%), nervousness (4%), fatigue (4%), insomnia (3%), anxiety (2%), and sleepiness (2%).² Except for the side effects, which are usually short lived and mild, patients report that they are largely unaware of being on medication.

Professor Rounsaville, Professor of Psychiatry at Yale University School of Medicine, USA and a leading international expert on alcohol dependency will be in Australia from 1 - 5 March 1999 to share with specialists and GPs his practical experience regarding REVIA's role in the treatment of alcohol dependency.

REVIA will be available in Australia from Orphan Australia, under licence from DuPont Pharmaceuticals Company USA, on private prescription from 1 March 1999. The treatment will be prescribed by Drug and Alcohol Specialists and GPs in conjunction with a comprehensive treatment program eg. counselling support.

Orphan Australia is a small pharmaceutical company that supplies pharmaceutical products typically used by specialists to treat serious disorders that affect relatively small populations.

References:

1. O'Malley SS, Croop RS, Wroblewski JM, Labriola DF, Volpicelli JR. Naltrexone in the Treatment of Alcohol Dependence: A Combined Analysis of Two Trials. Psychiatric Annals 25: 11 November 1995.
2. Croop RS, Faulkner EB, Labriola DF. The safety profile of naltrexone in the treatment of alcoholism: Results from a multicentre usage study. Archives of General Psychiatry. 1997; 54: 1130-35.

For further information contact:

Caroline Duell
Hill and Knowlton
(03) 9820 8999