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FDA Approves Pfizer's Schizophrenia Medicine Geodon (Ziprasidone Mesylate) In Injectable Form

First Atypical Antipsychotic Approved in Intramuscular Form To Rapidly Treat Acute Agitation in Patients with Schizophrenia

NEW YORK, NY -- June 25, 2002 -- Pfizer Inc said that the U.S. Food and Drug Administration has granted approval of Geodon for Injection (ziprasidone mesylate) 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.

"Geodon IM helps bring agitated patients under control rapidly with a low liability for the movement side effects that can be disturbing to patients and that may contribute to non-compliance with long-term treatment," said Dr. Joseph Feczko, Senior Vice President of Medical and Regulatory Operations at Pfizer.

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.

In a separate open-label study involving more than 550 patients, which was recently presented at the annual meeting of the American Psychiatric Association, those who received Geodon IM had comparable improvement in their agitation, significantly greater improvement in psychosis and significantly fewer movement disorders than patients who received the treatment standard Haldol IM. This improvement was either maintained or increased when patients were transitioned to oral therapy. The most common side effect with Geodon IM in this study was insomnia.

"Geodon IM is an important medical advance in the treatment of schizophrenia. It quickly controls agitated patients at a critical treatment point, reducing the need for heavily sedating drugs, which can cause confusion and further agitation in patients and make it difficult for physicians to evaluate and monitor them," said Dr. David G. Daniel, Clinical Professor of Psychiatry at George Washington University. "It's also important because, along with Geodon capsules, physicians now have one atypical treatment option to control both the acute and chronic phases of schizophrenia."

Geodon IM will be available through hospitals and clinics beginning in September.

Discovered and developed by Pfizer, Geodon is a serotonin and dopamine antagonist. The intramuscular form of Geodon, Geodon IM is for use in the treatment of acute agitation in schizophrenia. It is especially useful for patients for whom treatment with Geodon is appropriate and who need intramuscular medication for rapid control of their agitation. In addition to the United States, Geodon is the first atypical antipsychotic approved in intramuscular formulation in more than 15 countries, including Germany, Sweden, Spain and Brazil.

Oral Geodon received U.S. Food and Drug Administration approval for use in the treatment of schizophrenia in February 2001. It is also approved in more than 30 countries worldwide. To date, more than 200,000 patients in the United States alone have been prescribed Geodon.

Oral Geodon is associated with a prolongation of the QTc interval of the electrocardiogram, an effect seen with certain other marketed medicines, including some antipsychotics. This effect was well characterized in the extensive oral Geodon clinical trials database and is reflected in the FDA's product labeling, which suggests that physicians use their best judgment as to whether Geodon is the appropriate medication based on the overall status of the patient.

Pfizer Inc discovers, develops, manufactures and markets leading prescription medicines for humans and animals and many of the world's best-known consumer brands.


SOURCE: Pfizer Inc

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