Dott. Carlo Sebastiano Tadeo
INDIANAPOLIS, IN -- March 20, 2000 -- Eli Lilly and Company announced that the U.S. Food and Drug Administration (FDA) has approved Zyprexa(R) (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.(1)
Approximately 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,
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
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 four 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
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(R) (olanzapine, Lilly)
(2) Practice Guideline for Treatment of Patients with Bipolar Disorder.
American Psychiatric Association, 1995.
(3) Goodwin FK, Jameson, KR. Manic Depressive Illness. Oxford University
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