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From
a Pfizer Company Press Release - PR Newswire, June 24, 2002
Pfizer Inc said today that the U.S. Food and Drug Administration has granted
approval of Geodon for Injection (ziprasidonemesylate) to rapidly control
agitated behavior and psychotic symptoms such as hallucinations and delusions
in patients with acute exacerbations of schizophrenia. Geodon for Injection
is the first atypical antipsychotic medicine approved in the United States
for intramuscular (IM) use.
Acute
agitation is one of the most common psychiatric emergencies and is characterized
by uncooperative or even violent behavior that can be distressing and
dangerous. Because psychiatric emergencies require immediate intervention,
intramuscular antipsychotic medicines are critical because they are rapidly
effective.
In two clinical studies involving more than 175 patients, Geodon IM was
shown to be effective in rapidly reducing agitation and improving psychotic
symptoms, with statistical improvements seen within 30 minutes. Geodon
was well tolerated, with a favorable side effect profile and a very low
incidence of movement disorders. The most common side effects reported
among patients treated with Geodon IM were insomnia, nausea and headache.
These were characterized as mild to moderate in severity. Clinical trial
data also have shown that for patients who had been transitioned from
Geodon IM to Geodon capsules, improvement was maintained or increased
and was well tolerated.
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Early
Schizophrenia Screening Test 