Toviaz- uses and side effects

Toviaz (fesoterodine fumarate)
Potential health benefits 2008

APPROVAL / USE / INDICATIONS

The U.S. Food and Drug Administration has approved a new drug to help patients
suffering from overactive bladder (OAB). Toviaz (fesoterodine fumarate) works by
relaxing the smooth muscle tissue of the bladder, thus reducing the urinary
frequency, urge to urinate, and sudden urinary incontinence (leakage of urine), that
are characteristic symptoms of OAB.

Symptoms of OAB can have a profound effect on workplace productivity, social and
sexual activity and sleep. Overactive bladder may also lead to other health
problems, such as falls and fractures, urinary tract infections and skin disorders,
sleep problems and depression. [3]

STRENGTHS

Toviaz will be available by prescription only, as an extended release tablet in either 4
mg or 8 mg dosage strengths. It is to be administered once daily. The recommended
starting dose is 4 mg, which can be increased to 8 mg if needed, based upon
individual response and tolerability. Toviaz is only approved for adults.

MECHANISM

The safety and effectiveness of Toviaz were studied in two, 12-week, randomized
controlled studies of the 4 mg and 8 mg doses. For the combined studies, a total of
554 patients received placebo, 554 patients received Toviaz 4 mg daily, and 566
patients received the drug 8 mg daily. The majority of patients were female with a
mean age of 58 years. Toviaz is not approved for pediatric use.

In each of those two studies, the product showed a statistically significant and
clinically meaningful improvement in decreasing the number of times patients
needed to urinate per day, as well as the number of urine leaking episodes they
experienced per day, as compared to placebo.

COMMON SIDE EFFECTS

Common side effects associated with Toviaz included dry mouth and constipation.
Less frequently reported side effects included dry eyes and trouble emptying the
bladder.

SAFETY ISSUES / CONTRAINDICATION

Toviaz is not recommended in doses above 4 mg in those patients with severe
reduction in kidney function or in those patients taking medications, such as
ketoconazole, that block the metabolism of the drug. It should not be used in patients
who suffer from urinary or gastric retention or in patients with uncontrolled,
narrow-angle glaucoma. It should also not be used in patients with severe liver
impairment. The product should be used with caution in patients who suffer from
decreased gastrointestinal motility, such as those with severe constipation.

Health care professionals and consumers may report serious adverse events (side
effects) or product quality problems with the use of this product to the FDA's
MedWatch Adverse Event Reporting program either online, by regular mail, fax or
phone. Fax: (800) FDA-0178 --Phone: (800) FDA-1088

MANUFACTURER

Toviaz is manufactured by Schwarz Pharma of Zwickau, Germany and is distributed
by Pfizer Inc. of New York, N.Y.

SALES/MARKET/COMPETITION

The medicine may have about $500 million in peak annual sales and will compete
with Pfizer's Detrol and Detrol LA, which work similarly and had combined sales of
$1.2 billion last year.

Reference
[1] FDA News 2008 [2] Pfizer, UCB's Bladder Drug Toviaz Wins U.S. Approval
21food.com 03 Nov 2008 [3] Pfizer's TOVIAZ(TM) (fesoterodine fumarate) Receives
FDA Approval for the Treatment of Overactive Bladder sec.online.wsj.com
OCTOBER 31, 2008

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