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FDA Approved Drugs » 2008
Medical Areas: Nephrology

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Toviaz (fesoterodine fumarate)

The following drug information is obtained from various newswires, published medical journal articles, and medical conference presentations.

Company: Pfizer
Approval Status: Approved October 2008
Treatment Area: overactive bladder

General Information

Toviaz is an extended release tablet formulation of fesoterodine fumarate. Fesoterodine is a competitive muscarinic receptor antagonist. Muscarinic receptors play a role in contractions of urinary bladder smooth muscle and stimulation of salivary secretion. Inhibition of these receptors in the bladder is presumed to be the mechanism by which fesoterodine produces its effects.

Toviaz is specifically indicated for the treatment of overactive bladder with symptoms of urge urinary incontinence, urgency, and frequency.

Tovaiz is supplied as a a 4 mg or 8 mf extended release tablet. The recommended initla dose of the drug is 4 mg once daily. Based upon individual response and tolerability, the dose may be increased to 8 mg once daily. The daily dose of Toviaz should not exceed 4 mg in patients with severe renal insufficiency (CLCR <30 mL/min) and patients taking potent CYP3A4 inhibitors.

Clinical Results

FDA Approval
FDA approval of Tovaiz was based on two phase III trials. These randomized, double-blind, placebo-controlled, 12-week studies enrolled 554 subjects who received placebo, 554 subjects who received Toviaz 4 mg/day, and 566 subjects who received Toviaz 8 mg/day. The primary efficacy endpoints were the mean change in the number of urge urinary incontinence episodes per 24 hours and the mean change in the number of micturitions (frequency) per 24 hours.

Study One
The number of urge incontinence episodes per 24 hours showed a change from baseline of -1.20, -2.06 and -2.27 for placebo and Toviaz 4mg and 8mg arms, respectively (p=0.001 versus placebo). The number of micturitions per 24 hours showed a change from baseline of -1.02, -1.74 and -1.94 for placebo and Toviaz 4mg and 8mg arms, respectively (p<0.001versus placebo). The mean change in the voided volume per micturition from baseline, a secondary endpoint, was 10 mL, 27 mL and 33 mL for placebo and Toviaz 4mg and 8mg arms, respectively (p<0.001 versus placebo).

Study Two
The number of urge incontinence episodes per 24 hours showed a change from baseline of -1.00, -1.77 and -2.42 for placebo and Toviaz 4mg (p<0.003 versus placebo) and 8mg (p<0.001 versus placebo) arms , respectively. The number of micturitions per 24 hours showed a change from baseline of -1.02, -1.86 and -1.94 for placebo and Toviaz 4mg (p=0.032) and 8mg (p<0.001) arms, respectively. The mean change in the voided volume per micturition from baseline, a secondary endpoint, was 8 mL, 17 mL and 33 mL for placebo and Toviaz 4mg (p=0.150 versus placebo) and 8mg (<0.001) arms, respectively.

Side Effects

Adverse events associated with the use of Toviaz may include, but are not limited to, the following:

  • Dry mouth
  • Constipation
  • Urinary tract infection
  • Upper respiratory tract infection
  • Dry eyes
  • Dyspepsia
  • Abdominal pain

Mechanism of Action

Toviaz is an extended release tablet formulation of fesoterodine fumarate. Fesoterodine is a competitive muscarinic receptor antagonist. Muscarinic receptors play a role in contractions of urinary bladder smooth muscle and stimulation of salivary secretion. Inhibition of these receptors in the bladder is presumed to be the mechanism by which fesoterodine produces its effects.

Literature References

Chapple CR, Van Kerrebroeck PE, Jünemann KP, Wang JT, Brodsky M Comparison of fesoterodine and tolterodine in patients with overactive bladder. BJU International 2008 Jul 21

Kelleher CJ, Tubaro A, Wang JT, Kopp Z Impact of fesoterodine on quality of life: pooled data from two randomized trials. BJU International 2008 Jul;102(1):56-61

Khullar V, Rovner ES, Dmochowski R, Nitti V, Wang J, Guan Z Fesoterodine dose response in subjects with overactive bladder syndrome. Urology 2008 May;71(5):839-43

Nitti VW, Dmochowski R, Sand PK, Forst HT, Haag-Molkenteller C, Massow U, Wang J, Brodsky M, Bavendam T Efficacy, safety and tolerability of fesoterodine for overactive bladder syndrome. The Journal of urology 2007 Dec;178(6):2488-94

Chapple C, Van Kerrebroeck P, Tubaro A, Haag-Molkenteller C, Forst HT, Massow U, Wang J, Brodsky M Clinical efficacy, safety, and tolerability of once-daily fesoterodine in subjects with overactive bladder. European Urology 2007 Oct;52(4):1204-12

Additional Information

For additional information regarding Toviaz or overactive bladder, please visit the Toviaz web page.