Wednesday, pharmaceutical major Pfizer Inc (PFE) said that patients treated with Toviaz or fesoterodine fumarate 8 mg extended release tablets had greater and statistically significant reductions in urge urinary incontinence episodes at week 12 compared with Detrol LA or tolterodine tartrate extended release capsules in a placebo-controlled randomized clinical trial.
The company said that the primary endpoint of the study was reductions in urge urinary incontinence episodes. This new study, published today in the January issue of BJU International, is the first head-to-head superiority trial specifically designed to compare the two medications.
When looking at prespecified secondary endpoints, patients treated with Toviaz 8 mg had a significantly greater increase in the average volume of urine voided per micturition from baseline to week 12 compared with those who received Detrol LA. According to the report, the differences between Toviaz 8 mg and Detrol LA in urinary frequency and urgency episodes were not statistically significant.
"This is the first clinical trial that has been designed to assess the superiority of an antimuscarinic agent for the treatment of overactive bladder. This new data provides important information to physicians making treatment decisions for patients with overactive bladder since it compares two available medicines. This study showed that Toviaz 8 mg was significantly more efficacious than Detrol LA in treating urge urinary incontinence," said lead author Sender Herschorn, Sunnybrook Health Sciences Centre, Toronto.
According to the company, of the 1,712 patients enrolled in this 12-week, randomized, double-blinded, placebo-controlled superiority study, 1,697 were randomized to receive either Toviaz 8 mg, Detrol LA 4 mg or placebo once daily for 12 weeks. All patients in the Toviaz group started on Toviaz 4 mg for one week, followed by Toviaz 8 mg for 11 weeks.
The most frequently reported adverse events were dry mouth, headache and constipation. While dry mouth was reported in 28% of the Toviaz 8 mg group, 16% of the Detrol LA group and 6% in the placebo group, headache was reported in 6% of the Toviaz 8 mg group, 3% of the Detrol LA group and 2% of the placebo group. Constipation was reported in 5% of the Toviaz 8 mg group, 4% of the Detrol LA group and 3% of the placebo group. The company added that discontinuations due to treatment-related adverse events were 2% in the placebo group, 4% in the Detrol LA group and 6% in the Toviaz group.
Pfizer said that after the study was completed, additional analyses were done. In one post hoc analysis, patients in the study who were treated with Toviaz 8 mg showed statistically significant improvements over those treated with Detrol LA as assessed by the three-day diary dry rate at week 12. According to the report, Toviaz 8 mg also produced significantly greater improvements compared with Detrol LA as measured by the Patient Perception of Bladder Condition and Urgency Perception Scale at week 12.
Also in a post hoc analysis, patients in the study who were treated with Toviaz 8 mg showed significantly greater improvements over those treated with Detrol LA on all sections except one of the Overactive Bladder questionnaire, a questionnaire which assesses the bothersomeness of symptoms and health-related quality of life. At week 12, significant improvements were found in Symptom Bother and total health-related quality of life as well as the Concern, Coping and Social Interaction sections of the questionnaire; improvements in the Sleep section were not significant.
The company said that the results of a second head-to-head clinical trial with identical study design confirm the superiority of Toviaz 8 mg over Detrol LA 4 mg on the primary endpoint, urge urinary incontinence at week 12. As with this first trial, the results are planned to be submitted in 2010 for publication.
Toviaz is an FDA-approved, once-daily prescription treatment for patients with symptoms of overactive bladder. Affecting an estimated one in six people, overactive bladder symptoms include frequent and sudden urges to urinate and wetting accidents.
The reports said that the recommended starting dose of Toviaz is 4 mg once daily. Based upon individual response and tolerability, the dose may be increased to 8 mg once daily. The ability to titrate the dose of Toviaz allows physicians to customize treatment for each patient based on individual history and need. Toviaz is not recommended for patients with severe hepatic impairment.
Doses greater than 4 mg are not recommended in patients with severe renal insufficiency or in patients taking a potent CYP3A4 inhibitor; in patients taking a weak or moderate CYP3A4 inhibitor, careful assessment at 4 mg is advised prior to increasing to 8 mg.
PFE closed Wednesday's trade on the New York Stock Exchange at $18.41, up $0.12 or 0.66%. In the after hours the stock traded down $0.12 or 0.65%.
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