Study Shows Higher Dose Of Toviaz® (fesoterodine fumarate) Offers Greater Efficacy In Reducing Urge Urinary Incontinence In Patients With Overactive Bladder

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NEW YORK--(Business Wire)--
Pfizer Inc. (NYSE: PFE) announced today that a Phase 4 study assessing the
efficacy and safety of Toviaz® (fesoterodine fumarate) 8 mg once daily in
patients with overactive bladder (OAB) compared to Toviaz 4 mg once daily or
placebo met its primary endpoint. The primary endpoint was change in mean number
of urge urinary incontinence episodes per 24 hours from baseline to week 12.
Toviaz 8 mg reduced urge urinary incontinence in patients with OAB statistically
significantly more than Toviaz 4 mg. The efficacy of both doses was
statistically significant versus placebo. The recommended starting dose of
Toviaz is 4 mg once daily.

The safety and tolerability profile of both Toviaz doses in this study were
consistent with previous studies. Adverse events occurred more frequently among
subjects receiving the 8 mg dose of Toviaz than the 4 mg dose, and both doses of
Toviaz had adverse event rates greater than placebo. The most common
treatment-emergent adverse events were dry mouth, constipation and urinary tract
infection.

"We are aware of no other approved overactive bladder medication that has
demonstrated statistically superior efficacy of its higher dose versus lower
dose in reducing urge urinary incontinence in a randomized controlled
prospective study," said Steven J. Romano, M.D., senior vice president and
medicines development group head, Primary Care Business Unit, Pfizer Inc. "This
study further confirmed the efficacy of Toviaz 4 mg and the results show that
Toviaz 8 mg can further reduce symptoms in patients who require additional
efficacy beyond the 4 mg dose."

Urge urinary incontinence is the involuntary leakage of any amount of urine,
associated with or immediately preceded by a sense of urgency. Approximately 455
million adults worldwide, including 33 million American adults, are estimated to
suffer from OAB symptoms.

Study Background

The 12-week, randomized, double-blind, placebo-controlled, parallel-group study
assessed the efficacy of Toviaz 8 mg compared to Toviaz 4 mg in reducing urge
urinary incontinence in subjects with OAB after 12 weeks of treatment. Based on
a screening diary, all study participants who met all entry criteria started on
placebo. After two weeks, 1,955 subjects who received at least one dose of
double-blind study drug were randomized in a 2:2:1 ratio to either receive
Toviaz 8 mg (779 subjects), Toviaz 4 mg (790 subjects) or placebo (386
subjects). Subjects randomized to receive Toviaz 8 mg had their doses titrated,
starting on Toviaz 4 mg for the first week, followed by Toviaz 8 mg for the
remaining 11 weeks of the trial. No further dose adjustments were permitted for
the remaining 11 weeks of the study. The subjects were instructed to take the
study drug once every day in the morning.

The study was conducted at 246 sites in 27 countries. Further analyses will be
conducted and a publication of the comprehensive results is planned at a later
date.

Overactive bladder is a treatable medical condition often caused by involuntary
contractions or spasms of the bladder muscle. Overactive bladder symptoms of
urgency, frequency or urge urinary incontinence can be bothersome and can have a
significant impact on important aspects of people`s lives. Despite its
prevalence, OAB is often unrecognized and untreated.

About Toviaz

The recommended starting dose for Toviaz is 4 mg once daily. Based upon
individual response and tolerability, the dose may be increased to 8 mg once
daily. Toviaz should be swallowed whole; tablets should not be chewed, divided
or crushed.

INDICATION

Toviaz (fesoterodine fumarate) treats the symptoms of overactive bladder (leaks,
strong sudden urges to go, going too often).

IMPORTANT SAFETY INFORMATION

If you have certain stomach problems, glaucoma, or cannot empty your bladder,
you should not take Toviaz.

Toviaz may cause allergic reactions that may be serious. If you experience
swelling of the face, lips, throat, or tongue, stop taking Toviaz and get
emergency medical help right away.

Medicines like Toviaz can cause blurred vision, dizziness, drowsiness, and
decreased sweating. Do not drive, operate machinery, or do unsafe tasks until
you know how Toviaz affects you. Use caution in hot environments. Drinking
alcohol while taking medicines such as Toviaz may cause increased drowsiness.

The most common side effects are dry mouth and constipation. Toviaz has benefits
and risks. There may be other options. To learn more about Toviaz, please see
the Full Prescribing and Patient Information.

The recommended starting dose for Toviaz is 4 mg once daily. Based upon
individual response and tolerability, the dose may be increased to 8 mg once
daily. Toviaz should be swallowed whole; tablets should not be chewed, divided
or crushed.

Pfizer Inc.: Working together for a healthier world

At Pfizer, we apply science and our global resources to improve health and
well-being at every stage of life. We strive to set the standard for quality,
safety and value in the discovery, development and manufacturing of medicines
for people and animals. Our diversified global health care portfolio includes
human and animal biologic and small molecule medicines and vaccines; as well as
many of the world`s best-known consumer products. Every day, Pfizer colleagues
work across developed and emerging markets to advance wellness, prevention,
treatments and cures that challenge the most feared diseases of our time.
Consistent with our responsibility as the world`s leading biopharmaceutical
company, we also collaborate with health care providers, governments and local
communities to support and expand access to reliable, affordable health care
around the world. For more than 150 years, Pfizer has worked to make a
difference for all who rely on us.

Pfizer Inc.
Media:
Jennifer Kokell, 212-733-2596
Jennifer.Kokell@pfizer.com
or
Investors:
Suzanne Harnett, 212-733-8009
Suzanne.Harnett@pfizer.com

Copyright Business Wire 2013