Currently Enrolling Trials
Toviaz is specifically indicated for the treatment of overactive bladder with symptoms of urge urinary incontinence, urgency and frequency.
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.
Adverse events associated with the use of Toviaz may include, but are not limited to, the following:
- Dry mouth
- Urinary tract infection
- Upper respiratory tract infection
- Dry eyes
- Abdominal pain
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
Clinical Trial Results
FDA approval of Tovaiz was based on two phase 3 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.
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 (pStudy 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).
For additional information regarding Toviaz or overactive bladder, please visit the Toviaz web page.