Pfizer Receives FDA Approval For Geodon(R) (Ziprasidone HCI) Capsules For The Adjunctive Maintenance Treatment Of Bipolar Disord

NEW YORK, Nov 20, 2009 (BUSINESS WIRE) --
PFE | Quote | Chart | News | PowerRating -- Pfizer today announced that the U.S. Food and Drug Administration (FDA)
has approved Geodon(R) (ziprasidone HCI) Capsules for
maintenance treatment of bipolar I disorder as an adjunct to lithium or
valproate in adults. The approval is based on clinical data
demonstrating that Geodon is an effective and generally well-tolerated
adjunctive treatment for long-term symptom control in patients with
bipolar disorder.

Bipolar disorder, which affects approximately 5.7 million adults in the
United States, is a debilitating, chronic condition that requires
lifelong treatment and management.(1) More than 90 percent of
patients with bipolar disorder have recurring mood episodes,(2)
making it important to establish a long-term treatment plan to help
prevent recurrence and stabilize mood. The recurrence of mood episodes
associated with bipolar disorder can have a devastating impact on
patients' lives, and the disease is associated with high rates of
disability.(3)

"The FDA approval of Geodon provides an additional treatment option for
patients with bipolar disorder, who require maintenance therapy to keep
the symptoms of the disease under control," said Charles Bowden,
clinical professor of psychiatry and pharmacology, University of Texas
Health Science Center.

The efficacy and safety of Geodon for the adjunctive maintenance
treatment of bipolar disorder were studied in a six-month, double-blind,
randomized, placebo-controlled trial in adult patients with bipolar I
disorder. After an open-label stabilization period of 10 to 16 weeks,
240 patients were randomized to continue on Geodon plus lithium or
valproate, or to have Geodon replaced by placebo.(4) The
primary endpoint in this study was time to recurrence of a mood episode
requiring intervention.

The data demonstrated that Geodon plus lithium or valproate was superior
to placebo plus lithium or valproate in increasing the time to
recurrence of a mood episode. During six months of treatment, 19.7
percent of patients in the Geodon arm required intervention for a mood
episode, compared with 32.4 percent of patients in the placebo arm.(4)

The adjunctive Geodon treatment regimen was generally well-tolerated.(4)
Discontinuation due to adverse events occurred in 13 percent of patients
in the placebo group, compared with 9 percent of those in the Geodon
group.(5) The safety and tolerability data from this study are
consistent with Geodon's already well-established safety profile in
adult patients.

"The recurrence of mood episodes associated with bipolar disorder can
have a devastating impact on patients' lives," said Dr. Ilise Lombardo,
senior medical director, Pfizer Specialty Care. "This approval
underscores Pfizer's commitment to supporting people suffering from
serious mental health disorders."

Geodon is also FDA-approved for the treatment of acute manic and mixed
episodes associated with bipolar disorder, with or without psychotic
features, and for the treatment of schizophrenia. Since the FDA approval
of Geodon in February 2001, nearly 2 million adult patients have been
treated with this important therapy.(6)

Important Safety Information

Elderly patients with dementia-related psychosis treated with
antipsychotic drugs are at an increased risk of death compared to
placebo. Geodon is not approved for the treatment of elderly patients
with dementia-related psychosis.

Geodon is contraindicated in patients with a known history of QT
prolongation, recent acute myocardial infarction, or uncompensated heart
failure, and should not be used with other QT-prolonging drugs. Geodon
has a greater capacity to prolong the QTc interval than
several antipsychotics. In some drugs, QT prolongation has been
associated with torsade de pointes, a potentially fatal arrhythmia. In
many cases this would lead to the conclusion that other drugs should be
tried first.

As with all antipsychotic medications, a rare and potentially fatal
condition known as neuroleptic malignant syndrome (NMS) has been
reported with Geodon. NMS can cause hyperprexia, muscle rigidity,
diaphoresis, tachycardia, irregular pulse or blood pressure, cardiac
dysrhythmia, and altered mental status. If signs and symptoms appear,
immediate discontinuation, treatment, and monitoring are recommended.

Prescribing should be consistent with the need to minimize tardive
dyskinesia (TD), a potentially irreversible dose- and duration-dependent
syndrome. If signs and symptoms appear, discontinuation should be
considered since TD may remit partially or completely.

Hyperglycemia-related adverse events, sometimes serious, have been
reported in patients treated with atypical antipsychotics. There have
been few reports of hyperglycemia or diabetes in patients treated with
Geodon, and it is not known if Geodon is associated with these events.
Patients treated with an atypical antipsychotic should be monitored for
symptoms of hyperglycemia.

Precautions include the risk of rash, orthostatic hypotension, and
seizures.

In short-term schizophrenia trials, the most commonly observed adverse
events associated with Geodon at an incidence of greater-than or equal to 5% and at least twice
the rate of placebo were somnolence and respiratory tract infection.

The most common adverse events associated with Geodon in adult patients
with bipolar mania were somnolence, extrapyramidal symptoms, dizziness,
akathisia, and abnormal vision.

Please visit www.GEODON.com
for full prescribing and patient information.

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(1) National Institute of Mental Health. Bipolar disorder.
Available at: http://www.nimh.nih.gov/health/publications/bipolar-disorder/nimhbipolar.pdf.
Accessed October 27, 2009.

(2) Solomon DA, Keitner GI, Miller IW, Shea MT, Keller MB.
Course of illness and maintenance treatments for patients with bipolar
disorder. J Clin Psychiatry. 1995;56:5-13.

(3) Sajatovic M. Bipolar disorder: disease burden. Am J
Manag Care. 2005;11:S80-S84.

(4) Vieta E, Bowden C, Ice KS, et al. A 6-month, randomized,
placebo-controlled, double-blind trial of ziprasidone plus a mood
stabilizer in subjects with bipolar I disorder. Poster presented at the
17th European Psychiatric Association European Congress of Psychiatry,
January 25, 2009, Lisbon, Portugal.

(5) Pfizer Inc. Clinical study report synopsis: Protocol
A1281137. A phase 3, randomized, 6-month, double blind trial in subjects
with bipolar I disorder to evaluate the continued safety and maintenance
of effect of ziprasidone plus a mood stabilizer (vs placebo plus a mood
stabilizer) following a minimum of 2 months of response to open-label
treatment with both agents.

(6) Data on file. Pfizer Inc.

SOURCE: Pfizer Inc.

Pfizer 
Media: 
Gwen Fisher, 484-865-5160 
or 
Investors: 
Jennifer M. Davis, 212-733-0717

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