First treatment in nine years approved for bipolar mania in Canada - Zyprexa(r) helps control the symptoms of mania and prevents relapse

18 марта, 2003
TORONTO, March 18 /CNW/ - Today, Eli Lilly Canada Inc. announced that Zyprexa has been approved in Canada for the treatment of manic and mixed episodes associated with bipolar disorder, also known as manic depressive illness. Canada Newswire English via NewsEdge Corporation : TORONTO, March 18 /CNW/ - Today, Eli Lilly Canada Inc. announced that Zyprexa(r) (olanzapine) has been approved in Canada for the treatment of manic and mixed episodes associated with bipolar disorder, also known as manic depressive illness. Zyprexa is the first treatment in nine years approved for bipolar mania in Canada. Zyprexa provides rapid symptom control of a broad range of symptoms associated with mania and helps prevent relapse back into mania. "Zyprexa represents a significant advancement in the treatment of bipolar disorder," explains Dr. Roger McIntyre, Assistant Professor of Psychiatry at the University of Toronto. "A recent study showed that Zyprexa works better than Lithium, the current gold standard, in preventing manic episodes. In addition, ongoing studies show that Zyprexa manages both the manic and depressive phases of the illness." Bipolar disorder affects approximately one to two per cent of the adult population.(1) Bipolar disorder is a lifelong illness characterized by disruptive swings in mood--from euphoria and irritability (manic episodes), to periods of depression. A patient may experience either "pure" episodes (manic or depressive symptoms) or "mixed" episodes (a mixture of manic and depressive symptoms at the same time). In addition to the profound impact that the illness has on patients, there can be an equally severe impact on the patient's family and caregivers. Twenty-five to 50 per cent of people with bipolar disorder will attempt suicide at least once.(2) "When I'm in a manic phase my mind runs rapidly, I can't concentrate, I can become delusional and lose touch with reality. And in my depressed state nothing interests me. There seems no point in doing anything and everything seems too hard. It's overwhelming. Work is almost out of the question," explains Danny Marinus, bipolar patient. "It's awful for my family. They never know what mood I'll be in and what's going to happen next. Zyprexa has stabilized my mood and has helped me live a normal life again." "For patients, each day spent with manic or depressive symptoms can be devastating. Those afflicted with the illness suffer from severe mood swings to overwhelming feelings of sadness and low self-worth, which can include suicidal thoughts and even suicide," says Phil Upshall, President, Mood Disorders Society of Canada. "In addition to the profound impact that the illness has on patients, there can be an equally severe impact on the patient's family and caregivers. We welcome any new advancements that may help patients with bipolar disorder move forward with their lives." Clinical Trial Results In ongoing clinical trials with bipolar patients, Zyprexa has been shown to provide rapid symptom control, help patients remain in remission longer and help prevent relapse into mania: - Rapid symptom control in bipolar mania: studies show that Zyprexa demonstrated greater efficacy than placebo in the treatment of bipolar mania,(3,4) including a higher rate of response (65 per cent vs. 43 per cent respectively).(3) Zyprexa has been shown to produce a significantly greater improvement in symptoms of mania vs. divalproex(5) - Effective in depression symptoms: Zyprexa has been shown to manage depressive symptoms in patients with manic and mixed episodes. These symptoms are particularly resistant to standard anti-manic treatment. Nearly a seven-fold improvement in depressive symptoms was seen when Zyprexa was added to another mood stabilizer(6) - More effective than the current gold standard - lithium: a year-long study showed that in the maintenance treatment of bipolar disorder, patients taking Zyprexa relapsed into mania only half as often as patients taking lithium(6) Zyprexa is generally well tolerated. Adverse events reported in clinical trials included somnolence, dizziness and dry mouth, but rarely led to discontinuation of trial. As with other mood stabilizers, Zyprexa can also be associated with increased appetite leading to weight gain. The recommended beginning dose of Zyprexa to treat acute manic episodes is 10 milligrams in combination therapy or 15 milligrams by itself, taken once a day without regard to meals. Zyprexa is also indicated in Canada for the acute and maintenance treatment of schizophrenia and related psychotic disorders. Since introduced in 1996, Zyprexa has been prescribed to nearly 11 million people worldwide. Lilly, a leading innovation-driven corporation, is developing a growing portfolio of best-in-class pharmaceutical products by applying the latest research from its own worldwide laboratories and from collaborations with eminent scientific organizations. Headquartered in Indianapolis, Indiana, Lilly provides answers - through medicines and information - for some of the world's most urgent medical needs. Eli Lilly Canada, headquartered in Toronto, Ontario, employs more than 700 people across the country. Additional information about Eli Lilly Canada can be found at www.lilly.ca. NOTE TO EDITORS: Physician experts will be available for interviews in Toronto, Hamilton, Vancouver, Montreal and Moncton. NOTE TO TELEVISION STATIONS: B-Roll will be available on March 18th at the following coordinates: 10:00 am - 10:30 am (ET) and 13:30 pm - 14:00 pm (ET) Anik E2 C Band, Transponder 3B, Audio subcarrier 6.2 and 6.8 Downlink Frequency 3820 vertical References 1. Mood Disorders Society of Canada website, http://www.mooddisorderscanada.ca 2. Jamison KR. Suicide and bipolar disorder. J Clin Psychiatry 2000; 61 (Suppl 9):47-51 3. Tohen, M et al., Efficacy of olanzapine in acute bipolar mania. Arch Gen Psychiatry 2000;57:841-849 4. Tohen M et al., Olanzapine vs. placebo in the treatment of acute mania. Am J Psychiatry 1999; 156:702-709 5. Tohen M et al., Olanzapine versus divalproex in the treatment of acute mania Am J Psychiatry 2002; 159:1011-1017. 6. Tohen M et al., Olanzapine versus lithium in relapse prevention in bipolar disorder: a randomized double-blinded controlled 12-month clinical trial. Presented at the Third European Stanley Foundation Conference on Bipolar Disorder in Freiburg, Germany. VIEW ADDITIONAL COMPANY-SPECIFIC INFORMATION: http://www.newswire.ca/cgi-bin/inquiry.cgi?OKEY=86406 -0- 03/18/2003 /For further information: Please contact: Kent Hovey-Smith, Eli Lilly Canada, (416) 693-3879; Sabrina Paiva/Michelle Muise, GCI Group, (416) 486-2560/(416) 486-7272/ CO: ST: IN: SU: CNW 08:00e 18-MAR-03 <> << Copyright ©2003 Canada NewsWire >>
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