Toviaz Approved For Overactive Bladder Treatment
FDA on October 31st announced the U.S. marketing approval of fesoterodine fumarate (Toviaz) for the treatment of overactive bladder in adults.
According to FDA, fesoterodine relaxes smooth muscles in the bladder, leading to a reduction in urinary frequency, leakage, and the urge to urinate. Labeling for the product, which Pfizer will market as Toviaz, is not yet available.
FDA stated that fesoterodine will be available in 4- and 8-mg extended-release oral tablets. The recommended starting dosage is 4 mg per day, which can be increased to 8 mg per day, if needed, in patients who tolerate the drug well.
FDA described as "statistically significant and clinically meaningful" the reduction in urinary frequency and incontinent episodes in patients who received fesoterodine instead of a placebo during clinical trials.
Clinical trial results described in European Medicines Agency (EMEA)-approved labeling for fesoterodine indicate that the drug reduced by two the number of daily urinary episodes, compared with a reduction of one episode per day in placebo recipients.
In clinical trials of Toviaz for the treatment of overactive bladder in adults, common adverse events associated with the use of fesoterodine (Toviaz) included dry mouth and constipation, according to FDA. The agency stated that dry eyes and difficulty urinating were also reported during clinical trials but were less common.
FDA stated that daily fesoterodine dosages should not exceed 4 mg in patients who have severe kidney impairment or are being concomitantly treated with a potent inhibitor of cytochrome P-450 isoenzyme 3A4. Toviaz should not be used by patients with urinary or gastric retention or uncontrolled, narrow-angle glaucoma, according to FDA.