Posted by Shel on July 19, 2000, at 0:58:15
In reply to What is this Zyprexa? , posted by gritslad on July 18, 2000, at 15:13:12
Refer to http://www.zyprexa.com
Lilly Zyprexa® Approved for Treatment of Acute Mania Associated with Bipolar Disorder
Friday, March 17, 2000
Eli Lilly and Company has announced that the U.S. Food and Drug Administration (FDA) has approved
Zyprexa® (olanzapine) for marketing for the short-term treatment of acute manic episodes associated with
bipolar disorder.Bipolar disorder, also known as manic depressive illness, is a lifelong illness characterized by disruptive
swings in mood--from manic episodes, marked by euphoria and irritability, to periods of depression. Mania is
a period of abnormal elation and/or irritability, often accompanied by an unrealistic belief in one's own
abilities, increased sex drive, delusions, and alcohol or drug abuse. People with bipolar disorder also may
experience mixed episodes, marked by symptoms of mania and clinical depression occurring
simultaneously.1Approximately three million Americans suffer from bipolar disorder.2 An estimated one in four persons with
the illness attempts suicide, one of the highest incidence-rates for any psychiatric disorder.3"In short-term clinical trials, it appears that Zyprexa acts as a mood stabilizer to manage the manic phase of
bipolar illness easily, safely and effectively. Additionally, unlike some other medications, Zyprexa does not
require blood monitoring," said Mauricio Tohen, M.D., Dr. P.H., lead investigator, Lilly Research
Laboratories. "Zyprexa can stabilize mood in a range of bipolar patients with manic symptoms, potentially
avoiding impulsive or reckless behavior that can lead to serious problems."Mania associated with bipolar disorder, while manageable with proper therapy, can be difficult to diagnose
and, therefore, may be treated incorrectly."The majority of patients with bipolar disorder seek treatment during a depressive phase. This can leave the
manic phase of the disease undetected, leading to inappropriate treatment and worsening of symptoms,"
said Paul Keck, M.D., professor and vice chairman for research, University of Cincinnati College of Medicine.
"Accurate diagnosis and proper treatment are critical to managing the illness and allowing people the
chance to lead healthy, productive lives."Design and Results of Pivotal Trials
The FDA's approval of Zyprexa for the treatment of acute manic episodes associated with bipolar disorder
was based on results from two placebo-controlled trials involving patients with a primary diagnosis of bipolar
disorder: one three-week trial involving 67 patients and one four-week trial involving 115 patients. The trials
included patients with manic and mixed episodes, with or without psychotic features, and with or without a
rapid-cycling course.Zyprexa led to a significant improvement in mania, as measured by the Young-Mania Rating Scale (YMRS).
Zyprexa was generally well tolerated, with four adverse events reported significantly more frequently in the
Zyprexa group than in the placebo group: somnolence (drowsiness), dry mouth, dizziness and asthenia
(loss of strength). No participants discontinued the study due to any of these events. Other common events
that did not separate statistically from placebo were constipation, dyspepsia (indigestion), increased
appetite, and tremor.The recommended beginning dose of Zyprexa to treat acute manic episodes is 15 or 10 milligrams, taken
once a day, at any time, without regard to meals.Zyprexa also is indicated in the United States for the management of the manifestations of psychotic
disorders as demonstrated in short-term clinical trials with schizophrenia patients. Since Zyprexa was
introduced in 1996, it has been prescribed to nearly 4 million people worldwide.In the original schizophrenia registration trials, Zyprexa was generally well tolerated. However, as with all
medications, Zyprexa was associated with some side effects. In the original six-week, acute-phase
schizophrenia trials, the most common treatment-emergent adverse event associated with Zyprexa was
somnolence. Other common events were dizziness, weight gain, constipation, akathisia (restlessness) and
postural hypotension. Modest elevations of prolactin were also seen, although mean changes from baseline
to endpoint were not statistically significantly different between Zyprexa and placebo. A small number of
patients experienced asymptomatic elevations of hepatic transaminase; none of these patients developed
jaundice or drug-induced hepatitis. Full prescribing information is available via fax option by calling
1-800-753-0352, extension 718.Eli Lilly and Company is a global research-based pharmaceutical corporation headquartered in Indianapolis,
Ind., that is dedicated to creating and delivering innovative pharmaceutical-based health care solutions that
enable people to live longer, healthier and more active lives.___________________________________________
Zyprexa® (olanzapine, Lilly)
References:
1.Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition (DSM-IV). American
Psychiatric Association, 1994.
2.Practice Guideline for Treatment of Patients with Bipolar Disorder. American Psychiatric
Association, 1995.Goodwin FK, Jameson, KR. Manic Depressive Illness. Oxford University Press, 1990
poster:Shel
thread:40866
URL: http://www.dr-bob.org/babble/20000717/msgs/40928.html