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New Schizophrenia Treatment Now Available in Canada

Leger Marketing Research Shows Strong Stigma Associated to Disease Affecting More Than 300,000 Canadians

MONTREAL, Feb. 6 /CNW/ - Canadians with schizophrenia now have a new treatment option to manage their disease. Health Canada has approved ZELDOX (TM) (ziprasidone hydrochloride) for the treatment of schizophrenia and related psychotic disorders, bringing an important additional option to manage this chronic complex mental illness, which is highly stigmatized and misunderstood.
    
New research from Léger Marketing reveals the extent of the stigma associated with the disease. Seventy per cent of Canadians feel that those who suffer from schizophrenia are not always treated the same way as people who are not afflicted with the disease. Even more surprising is the fact that among those Canadians who have been personally diagnosed or know someone who has schizophrenia, 44 per cent say they would be uncomfortable having a person with schizophrenia spend the weekend in their home.
    
"ZELDOX(TM) is a welcome new treatment option because it controls the symptoms of schizophrenia and appears to cause less weight gain than other antipsychotic medications. Weight gain can increase the risk of developing diabetes and heart disease. These side effects are often distressing and stigmatizing and are a major reason that patients go off their medication," said Dr. Ashok Malla, Director of the Prevention and Early Intervention Program for Psychoses at the Douglas Mental Health University Institute in Montreal, Quebec. "ZELDOX(TM) has demonstrated an excellent safety and efficacy profile as demonstrated through over a decade of research and patient experience."
    
The Léger survey revealed the low level of awareness among Canadians about the impact of the side effects associated with many medications that are used to treat schizophrenia. Only one in ten Canadians (10 per cent) believes that those with schizophrenia stop their treatment due to weight gain and other side effects. Surprisingly, 57 per cent of Canadians who have been or know someone that has been diagnosed with schizophrenia believe that people with the illness stop their treatment because they are well enough.
    
In Canada, one in every hundred persons lives with schizophrenia - over 300,000 Canadians in all. It is characterized by symptoms such as delusions, hallucinations, unusual suspiciousness, becoming withdrawn, and becoming depressed or anxious. People who suffer from schizophrenia have difficulty performing tasks that require abstract memory and sustained attention.
    
Mary K. was diagnosed with schizophrenia in 2001. Frustrated by the fact that the first treatment she took caused her to gain upwards of 20 pounds, she found herself feeling exhausted and hungry all the time and she was unable to hold down a job. When her psychiatrist suggested that she participate in a clinical trial evaluating the efficacy of ziprasidone, she was enthusiastic at the prospect of trying a new treatment. Almost immediately after taking ZELDOX(TM), Mary was able to lose the weight she had gained and feel more energized. She was able to go back to school, earn a diploma and obtain a steady job. She has now been taking ZELDOX(TM) for the treatment and management of her schizophrenia for the past five years through a clinical trial.
    
"Since I began taking ZELDOX(TM), I can not only manage my symptoms, but I don't experience any of the side effects such as weight gain that were typical of other medications I had taken. ZELDOX(TM) has enabled me not only to regain control of my life but it has allowed me to enjoy my life."    

The precise cause of schizophrenia remains unknown and there is no definitive cure. In 2006, the total cost of schizophrenia (both direct and
indirect) in Canada was estimated to be $4.35 billion. It also places a substantial financial burden on sufferers themselves and their caregivers.
    
"The approval of ZELDOX(TM) represents a significant step forward for Canadians living with schizophrenia. It provides them with another option with which to treat this chronic mental condition, a condition that has a significant impact not only on individuals living with schizophrenia, but also on their families and on society," said Dr. Bernard Prigent, Vice-President, Medical Affairs, Pfizer Canada.

About ZELDOX(TM)

 Discovered and developed by Pfizer, ZELDOX(TM) is a serotonin and dopamine antagonist which treats the symptoms characterized as both positive (e.g. visual and auditory hallucinations) and negative (lack of motivation and social withdrawal) as well as the overall psychopathology of the disease.
    
The efficacy of ZELDOX(TM) in the treatment of schizophrenia was established in the largest ever clinical trials program conducted for a novel antipsychotic medication prior to launch. The program involved four short-term and one long-term placebo-controlled clinical trials of psychotic inpatients who met the DSM-III-R criteria for schizophrenia. Each study included 2-3 fixed doses of ZELDOX(TM) as well as placebo. In clinical trials, ZELDOX(TM) demonstrated excellent positive, negative, and affective symptom efficacy as well as improvement in social impairment and cognitive symptoms in switch studies at 6 weeks versus olanzapine and risperidone. Several instruments were used to assess psychiatric signs and symptoms in these studies, among them the Brief Psychiatric Rating Scale (BPRS) and the Positive and Negative Syndrome Scale (PANSS), both multi-item inventories of psychopathology traditionally used to evaluate the effects of drug treatment in psychosis.
    
As with many other atypical antipsychotics, the exact mechanism of action of ZELDOX(TM) is unknown. However, it has been proposed that the efficacy of this drug in schizophrenia is mediated through a combination of dopamine type 2 (D2) and serotonin type 2 (5HT2) antagonism. ZELDOX(TM) is the only atypical antipsychotic with data showing long-term improvement in metabolic parameters including weight, cholesterol and triglycerides. The most common side effects of ZELDOX(TM) include fatigue, nausea or upset stomach, constipation, dizziness, restlessness, abnormal movements, diarrhea, rash or increased cough/runny nose. One potential side effect of ZELDOX(TM) is that it may induce an abnormal heart rhythm, a risk that can be increased in patients who already have certain abnormal heart conditions or in those who are taking certain medications. ZELDOX(TM) is not recommended in patients who have Long QT Syndrome (LQTS), those who have had a recent heart attack, severe heart failure or certain irregularities of heart rhythm.
    
ZELDOX(TM) has been approved in 89 other countries worldwide and is marketed under the brand name GEODON in some countries, including the United States.

About Pfizer Canada Inc.

Pfizer Canada Inc. is the Canadian operation of Pfizer Inc, the world's leading pharmaceutical company. Pfizer discovers, develops, manufactures and markets prescription medicines for humans and animals. Pfizer's ongoing research and development activities focus on a wide range of therapeutic areas following our guiding aspiration...Working for a healthier world. For more information, visit www.pfizer.ca.

     ZELDOX, Pfizer Products Inc.


 

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/For further information: Christina Antoniou, Pfizer Canada, (514)
693-4766 or (514) 208-5960, christina.antoniou@pfizer.ca; Sandra Cruickshanks,
Thornley Fallis Communications, (416) 515-7517 x248,
cruickshanks@thornleyfallis.com; Farah Meghji, Thornley Fallis Communications,
(416) 515-7517 x249, meghji@thornleyfallis.com/


 

Posted: February 2008


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