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Media Release - 31 January 2000

First anti-craving drug to treat alcohol dependence available on PBS

-ReVia® (naltrexone HCI) PBS listed 1 February 2000-


ReVia (naltrexone HCI) will be available Authority Listed on the Pharmaceutical Benefits Scheme (PBS) from 1 February 2000 for use within a comprehensive treatment programme for alcohol dependence.

Dr Stephen Jurd, Director, Drug and Alcohol Services, Royal North Shore Hospital, Sydney, said that the PBS listing of Naltrexone offers patients an affordable choice of treatment for alcohol dependence.

"Naltrexone is the first in, what could be termed, a new class of anti-craving drugs shown to decrease the relapse rate in alcohol dependence. In fact, Naltrexone has been shown to work in severe cases of alcoholism such as patients with a strong family history and high craving scores. Patients with impairment to their higher brain centres also show a good response," said Dr Jurd.

Dr Jurd said that the crucial message is that alcohol dependence is a treatable disease. "In the past, it was deemed appropriate to treat alcohol dependence as a behaviour," he said. "But now there is scientific, genetic and biological evidence, to support the notion of alcohol dependence as a serious brain disease that requires appropriate medical intervention," he said.

Clinical trials in the United States and Australia have shown that ReVia, when used as part of a comprehensive treatment programme, improves clinical outcomes. ReVia has been shown to prevent relapse; reduce craving, drinking days and volume; as well as increase abstinence. 1,2,3

"Pharmacotherapy for alcoholism is not just a flash in the pan. It can truly add value to current treatments. I congratulate the government for reinforcing this view, by funding effective pharmacotherapy for alcohol dependent patients," said Dr Jurd.

Pre-clinical evidence suggests a simple mechanism of action for ReVia. Alcohol causes the release of endogenous opioids which then stimulate the opioid receptor, producing reward sensation and reinforcing continued drinking. ReVia, a pure opioid antagonist, blocks the opioid receptor decreasing the reward sensation and thereby diminishing the need for continued drinking.

ReVia is presented as 50 mg tablets and is convenient as a once-a-day treatment taken with or without meals. The recommended course of treatment is a minimum of three months.

Most patients with alcohol dependence can be treated by their GP, but the more severely dependent patients or those with comorbid conditions may be best referred to a specialist for initial treatment eg. patients requiring detoxification from alcohol, or psychiatric treatment.

ReVia is generally well tolerated. A clinical safety study of ReVia (570 individuals) has shown that most side effects are usually mild and transient. More than 62% reported no new adverse events, compared to 82% in the reference group, with the most common side effects being nausea and headache.4 Orphan Australia advises that ReVia is contraindicated in patients receiving opioid drugs.

ReVia does not affect a person's blood alcohol level. If a patient drinks alcohol during treatment, their blood alcohol level will increase as normal, causing the normal physical and mental impairments.

In Australia, alcohol-related problems affect around six to seven per cent of the population and are responsible for approximately 6,000 deaths each year. Alcohol dependency costs the country in excess of $6 billion annually. 5 Alcohol use disorders are approximately three times as common as drug use disorders. 6

Orphan Australia, distributor of ReVia under licence from DuPont Pharmaceuticals Company USA, advises that from 1 February, there will also be an effective decrease in the price for non-PBS subsidised private prescriptions for opiate dependent patients. This is due to a common wholesale price for the supply of ReVia.


PBS Listed: February 1st, 2000 Authority Required - "For use within a comprehensive treatment program for alcohol dependence with the goal of maintaining abstinence." ( See Late Amendments (page 12) of Schedule of Pharmaceutical Benefits, February 2000)

References:

1. Volpicelli VR e.al. Naltrexone in the Treatment of Alcohol Dependence Arch. Gen. Psych. 1992 49:881-887

2. Anton R., et.al. Naltrexone and cognitive behavioural therapy for the treatment of alcoholics: Results of a placebo-controlled trial. Am. J. Psych. 1999;156:1758-64

3. O'Malley et.al. Naltrexone and Coping Skills Therapy for Alcohol Dependence. A Controlled Study. Arch. Gen. Psych. 1992; 49:881-887

4. 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

5. World Health Organisation

6. 1997 National Survey of Mental Health and Wellbeing of Adults, ABS.


For further information contact: Caroline Duell, Hill and Knowlton (03) 9211 2444


Orphan Australia Pty Ltd. 48 Kangan Drive, Berwick Victoria, 3806 Australia

Telephone : 61 3 9769 5744 ----- Facsimile : 61 3 9769 5944 ----- Email : info@orphan.com.au

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