SERTINDOLE SHOWS PROMISE IN SCHIZOPHRENIA
NEW YORK, May 8 /PRNewswire/ -- Today at the annual meeting of the
American Psychiatric Association (APA), data were presented describing the
use of Serlect (sertindole) in the treatment of psychosis. The study
results suggest that sertindole may provide a new alternative in the
management of schizophrenia and other forms of psychosis.
"Schizophrenia affects as many as one out of 100 people in the
U.S. It is a devastating illness and many patients often do not respond
to treatments currently available, or only partially improve and remain
functionally impaired. These study results suggest sertindole may offer
hope to people affected by this disabling illness," says Dan Zimbroff,
M.D., of Loma Linda University, who presented the study results at APA.
THE STUDY RESULTS
The multi-center, double-blind, eight-week clinical trial compared
three doses of sertindole (12, 20 and 24 mg/day) to three doses of
haloperidol (4, 8 and 16 mg/day) and placebo. In the study, all
sertindole doses and haloperidol doses showed significant improvement in
the positive symptoms of schizophrenia compared with placebo and in
reducing the total scores on the Positive and Negative Symptoms Scale
(PANSS). Only sertindole at a dose of 20 mg/day reduced negative
symptoms, as measured by PANSS Negative Symptom Subscale and total Scale
for the Assessment of Negative Symptoms (SANS). On a comprehensive,
global scale of improvement (the Clinical Global Impression scale or CGI),
all doses of sertindole and haloperidol were associated with significant
improvement compared to placebo.
Patients using haloperidol experienced motor side effects called
extrapyramidal symptoms, or EPS, at rates significantly higher than
placebo. EPS-profiles for sertindole were clinically and statistically
indistinguishable from placebo. In addition, patients treated with any of
the three doses of sertindole exhibited significantly less EPS than
patients using any of the three doses of haloperidol. Researchers
measured EPS-rates by the number of EPS-related adverse events, use of
anti-EPS medication and three standardized movement rating scales. This
EPS profile is important because EPS can cause extreme discomfort, be
confused with psychotic symptoms and reduce treatment compliance.
Statistically, the adverse events that occurred more often with
sertindole than placebo included nasal congestion and decreased
ejaculatory volume. The adverse events that occurred more often with
haloperidol than placebo were EPS-related.
THE IMPACT
Schizophrenia is a devastating, chronic mental disorder that affects
an estimated one out of 100 people. It is characterized by a
disintegration in the process of thinking, of contact with reality, and
of
emotional responsiveness. The condition, which generally manifests early
in adulthood, costs America approximately $16-$33 billion annually and
accounts for 25 percent of all hospital beds in use. Patients with
schizophrenia often do not respond to currently available treatments or
only partially improve. In nearly 25 percent of patients who do not
respond or remain functionally impaired, the condition is so poorly
managed with traditional treatments that they require custodial care.
THE COMPOUND
In September 1995, Abbott submitted a New Drug Application to the U.S.
Food and Drug Administration for the use of sertindole in the treatment
of
psychotic disorders. Sertindole is licensed for marketing in the United
States, Canada, and Latin America by Abbott Laboratories from H. Lundbeck
A/S of Denmark.
As demonstrated in pre-clinical studies, sertindole is a potent
antagonist at D2, 5HT2 and alpha1 receptors without activity at
histaminic, muscarinic or alpha2 receptors. This selectivity suggests
that sertindole should not produce sedative effects or anticholinergic
effects (such as constipation and dry mouth) related to those receptors.
Abbott Laboratories (NYSE: ABT) is a worldwide manufacturer of
health care products, employing 50,000 people. In 1995, the company's
sales and net earnings were $10.0 billion and $1.7 billion, respectively,
with earnings per share of $2.12.
CO: Abbott Laboratories
ST: Illinois
IN: MTC
SU: