|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. 
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
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
Toviaz is manufactured by Schwarz Pharma of Zwickau, Germany and is distributed by Pfizer Inc. of New
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.
 FDA News 2008  Pfizer, UCB's Bladder Drug Toviaz Wins U.S. Approval 21food.com 03 Nov 2008
 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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