Promising new treatment option helps keep Canadians sober

    TORONTO, Dec. 13 /CNW/ - Today, Canadian pharmacies for the first time
will be stocked with CAMPRAL(R) (acamprosate calcium, 333 mg), a prescription
medication to treat alcohol dependence - a disease estimated to affect 600,000
Canadians.(1) Approved by Health Canada this year, this medication is
effective and safe in increasing both continuous abstinence from alcohol and
the number of alcohol-free days.
    Alcohol dependence is now recognized as a chronic brain disease,
characterized by long-term, if not permanent, changes in the neurochemical
properties of the brain.(2) These long-lasting changes in the brain are
believed to form the core of alcohol dependence. Acceptance of alcohol
dependence as a disease, rather than a lifestyle choice, has led to the
increasing use of medication in conjunction with appropriate psychosocial
support as an effective approach for the treatment of this disease.
    "Alcohol dependence is a real public health concern. It is associated
with more than 18,000 deaths in Canada every year," said Dr. Milan Khara, an
Addiction Medicine Physician with Vancouver Coastal Health. "Although many
patients successfully go through detoxification, the reality is the risk of
relapse remains high. After more than a decade, there is now a new treatment
option in Canada that is effective in helping patients abstain from alcohol.
When used in combination with counselling or psychosocial support, CAMPRAL(R)
can play a significant role in maintaining abstinence in detoxified
alcohol-dependent patients," added Khara.

    Unlike other medications, CAMPRAL(R) acts in two ways

    CAMPRAL(R) is a treatment that both assists in the maintenance of
abstinence from alcohol and decreases withdrawal symptoms, reducing the chance
of relapse. Its mechanism of action is different from that of the two other
medications previously approved in Canada for the treatment of alcohol
dependence. The first, disulfiram, has a poor toxicity profile. It is no
longer distributed in Canada, although it can still be prescribed under
specific circumstances. The second agent, naltrexone, reduces the rewarding
effects of alcohol thereby reducing a person's cravings to drink.(3)
    CAMPRAL(R) also has a lower hepatic toxicity. Therefore, unlike
naltrexone, it can be prescribed to patients with significant liver damage.

    Studies show significantly higher abstinence rates

    Clinical studies have been conducted with more than 4,200
alcohol-dependent patients around the world. Highlights from these studies
    -  CAMPRAL(R) is significantly superior to placebo on all efficacy
    -  The advantages over placebo could be seen as early as 30 days into
       treatment and were sustained for the remainder of treatment, as well
       as the one-year follow-up period without study medication.
    -  Cumulative abstinence duration may increase by 50 to 65 per cent.
    -  Treatment with CAMPRAL(R) from early in the post-weaning phase
       provides better relapse control compared to placebo.
    -  CAMPRAL(R) is well tolerated without signs of psychotropic side
       effects or potential for abuse or dependence.

    "Based on data gathered from numerous clinical trials from around the
world, it is evident this new agent is effective and well tolerated by most
patients," said Dr. Juan Carlos Negrete, Professor of Psychiatry, McGill
University and Senior Consultant, Addictions Unit, McGill University Health
Centre. "CAMPRAL(R) has been shown to increase both continuous abstinence and
the number of alcohol-free days versus placebo. More importantly, these
effects persist during the long-term and are maintained following cessation of
treatment which helps to increase a person's chances of success in remaining
    CAMPRAL(R) should be taken only by alcohol-dependent patients who have
undergone detoxification or who are currently abstaining from alcohol. The
recommended standard dosage is two 333 mg tablets taken three times daily. The
most common side effects are transient and may include diarrhea, abdominal
pain, gas, nausea and itching.
    In Canada, CAMPRAL(R) retails for $0.80 per tablet or $67.20 for blister
packs of 84 tablets.

    About Alcohol Dependence

    In Canada, alcohol abuse and dependence accounts for approximately
$7.52 billion in annual costs(4) and resulted in over 1.5 million days of
acute care in hospitals in 2002.(5) In addition, a number of health issues can
be attributed to alcohol dependence, including:
    -  serious disease of the pancreas;
    -  illness and death from liver disease;
    -  low blood sugar;
    -  chronic depression; and
    -  numerous forms of cancer (i.e., stomach, colon, rectal, liver, breast
       and ovarian).

    About Prempharm

    Prempharm, based in Toronto, holds licensing agreements with various
international pharmaceutical companies and is now owned by Mylan Inc.
Prempharm is committed to becoming a partner of choice amongst addiction
healthcare providers by supporting their clinical and educational initiatives
focused on improving outcomes for persons living with alcohol dependence.



    (1) Tjepkema M. Alcohol and illicit drug dependence. Supplement of Health
        Reports 2004;15:9-53.
    (2) Tambour S, Quertemont E. Preclinical and clinical pharmacology of
        alcohol dependence. Fundamental & Clinical Pharmacology,
    (3) Sinclair JD. 2001. Evidence about the use of naltrexone and for
        different ways of using it in the treatment of alcoholism. Alcohol
        Alcohol, 36:2-10.
    (4) Single E, Robson L, Xie X, Rehm J. The economic costs of alcohol,
        tobacco and illicit drugs in Canada, 1992. Addiction.
    (5) The Cost of Substance Abuse in Canada. (Available at:
        a/TheCostsofSubstanceAbuseinCanada.htm. Accessed July 9, 2007).

For further information:

For further information: (or to schedule an interview) please contact
Meryn Jackson, Six Degrees Medical Consulting, (416) 594-6072, or Kendal Lo, Six Degrees Medical Consulting, (416)

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