FDA Approves Injectable Geodon

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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