eMIMS New Product
New drug - Toviaz
27-Jun-08
PHARMACOLOGY
Fesoterodine is a competitive, specific muscarinic receptor antagonist. It is rapidly and extensively hydrolysed by non-specific plasma esterases to the 5-hydroxymethyl derivative, its primary active metabolite.
CLINICAL STUDIES
The efficacy of fesoterodine has been assessed in two phase III 12-week trials1,2 in patients with overactive bladder syndrome.
Patients were randomised to placebo, 4mg fesoterodine or 8mg fesoterodine once daily for 12 weeks. The primary efficacy end point was the change in the number of micturitions per 24 hours. Co-primary end points were the change in the number of urgency urinary incontinence (UUI)episodes per 24 hours and the treatment response.
The trials showed statistically significant and clinically relevant improvements in primary and co-primary end points in patients taking 4mg fesoterodine and 8mg fesoterodine compared to placebo.
References:
1. Chapple C, Van Kerrebroeck P, Tubaro A et al. Clinical efficacy, safety and tolerability of once-daily fesoterodine in subjects with overactive bladder. Eur Urol 2007: 52; 1204–12.
2. Nitti V, Dmochowski R, Sand P et al. Efficacy, safety and tolerability of fesoterodine for overactive bladder syndrome. J Urol 2007: 178; 2488–94.
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