Drugs

, Volume 69, Issue 6, pp 731–738 | Cite as

Fesoterodine

Adis Drug Profile

Abstract

  • ▴ Fesoterodine is a muscarinic receptor antagonist that is rapidly and extensively converted to the active and more potent metabolite 5-hydroxymethyltolterodine. The drug is approved for once-daily oral administration in patients with overactive bladder syndrome (OAB).

  • ▴ In two large, 12-week, randomized, double-blind, multicentre, phase III trials, oral fesoterodine 4 or 8 mg once daily improved the symptoms of OAB (frequency of micturition, urgency and urge incontinence) significantly more than placebo.

  • ▴ Furthermore, significantly more patients receiving fesoterodine 4 or 8mg once daily had a positive response to therapy than those receiving placebo, as determined by a treatment questionnaire.

  • ▴ Health-related quality of life was improved to a significantly greater extent in patients with OAB who received fesoterodine 4 or 8 mg once daily than in those who received placebo in a post hoc analysis of pooled data from the phase III trials.

  • ▴ Fesoterodine 4 or 8 mg once daily was generally well tolerated in patients with OAB; the most frequent adverse event was dry mouth, which was generally mild to moderate in severity.

Keywords

Oxybutynin Urge Incontinence Tolterodine Poor Metabolizers Extensive Metabolizers 

Notes

Acknowledgements and Disclosures

The manuscript was reviewed by: A. Beaven, Department of Urology, North Shore Hospital, Auckland, New Zealand. H. Hashim, Bristol Urological Institute, Southmead Hospital, Bristol, UK; R. Millard, Department of Urology, Prince of Wales Hospital, Sydney, New South Wales, Australia.

The preparation of this review was not supported by any external funding. During the peer review process, the manufacturer of the agent under review was offered an opportunity to comment on this article. Changes resulting from comments received were made on the basis of scientific and editorial merit.

References

  1. 1.
    Staskin DR, MacDiarmid SA. Pharmacologic management of overactive bladder: practical options for the primary care physician. Am J Med 2006 Mar; 119 (3 Suppl. 1): 24–8PubMedCrossRefGoogle Scholar
  2. 2.
    Irwin D, Milsom I, Reilly K, et al. Population-based survey of urinary incontinence, overactive bladder and other lower urinary tract symptoms in five countries: results of the EPIC study. Eur Urol 2006; 50(6): 1306–15PubMedCrossRefGoogle Scholar
  3. 3.
    De Groat WC. A neurologic basis for the overactive bladder. Urology 1997; 50 Suppl. 6A: 36–52PubMedCrossRefGoogle Scholar
  4. 4.
    Dmochowski R. Improving the tolerability of anticholinergic agents in the treatment of overactive bladder. Drug Saf 2005; 28(7): 583–600PubMedCrossRefGoogle Scholar
  5. 5.
    Michel MC. Fesoterodine: a novel muscarinic receptor antagonist for the treatment of overactive bladder syndrome. Expert Opin Pharmacother 2008; 9(10): 1787–96PubMedCrossRefGoogle Scholar
  6. 6.
    Pfizer Labs. Toviaz™ (fesoterodine fumarate) extended release tablets: prescribing information [online]. Available from URL: http://media.pfizer.com/files/products/uspi_toviaz.pdf [Accessed 2008 Dec 1]
  7. 7.
    European Medicines Agency. Toviaz 4 mg prolonged-release tablets: summary of product characteristics [online]. Available from URL: http://www.emea.europa.eu/humandocs/PDFs/EPAR/toviaz/H-723-PI-en.pdf [Accessed 2008 Nov 27]
  8. 8.
    Ney P, Pandita RK, Newgreen DT, et al. Pharmacological characterization of a novel investigational antimuscarinic drug, fesoterodine, in vitro and in vivo. BJU Int 2008; 101(8): 1036–42PubMedCrossRefGoogle Scholar
  9. 9.
    Mansfield KJ, Liu L, Mitchelson FJ, et al. Muscarinic receptor subtypes in human bladder detrusor and mucosa, studied by radioligand binding and quantitative competitive RT-PCR: changes in ageing. Br J Pharmacol 2005; 144(8): 1089–99PubMedCrossRefGoogle Scholar
  10. 10.
    Malhotra B, Wood N, Holbrook M, et al. Thorough QT study to evaluate the effect of fesoterodine on cardiac repolarization [abstract no. P052]. Fundam Clin Pharmacol 2008; 22 (Suppl. 2): 68Google Scholar
  11. 11.
    Malhotra B, Guan Z, Wood N, et al. Pharmacokinetic profile of fesoterodine. Int J Clin Pharmacol Ther 2008; 46(11): 556–63PubMedGoogle Scholar
  12. 12.
    Nitti VW, Dmochowski R, Sand PK, et al. Efficacy, safety and tolerability of fesoterodine for overactive bladder syndrome. J Urol 2007; 178(6): 2488–94PubMedCrossRefGoogle Scholar
  13. 13.
    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(4): 1204–12PubMedCrossRefGoogle Scholar
  14. 14.
    Chapple C. Fesoterodine a new effective and well-tolerated antimuscarinic for the treatment of urgency-frequency syndrome: results of a phase 2 controlled study [abstract no. 142 plus poster]. 34th Annual Meeting of the International Continence Society; 2004 Aug 23–27; ParisGoogle Scholar
  15. 15.
    Nitti V, Wiatrak M, Kreitman L, et al. Fesoterodine is an effective antimuscarinic for patients with overactive bladder: results of a phase 2 trial [abstract no. 306 plus poster]. 35th Annual Meeting of the International Continence Society; 2005 Aug 31–Sep 2; Montreal (QC)Google Scholar
  16. 16.
    Kelleher CJ, Tubaro A, Wang JT, et al. Impact of fesoterodine on quality of life: pooled data from two randomized trials. BJU Int 2008; 102(1): 56–61PubMedCrossRefGoogle Scholar
  17. 17.
    Colman S, Chapple C, Nitti V, et al. Validation of treatment benefit scale for assessing subjective outcomes in treatment of overactive bladder. Urology 2008; 72(4): 803–7PubMedCrossRefGoogle Scholar
  18. 18.
    Khullar V, Rovner ES, Dmochowski R, et al. Fesoterodine dose response in subjects with overactive bladder syndrome. Urology 2008; 71(5): 839–43PubMedCrossRefGoogle Scholar
  19. 19.
    Chapple CR, Van Kerrebroeck PE, Jünemann K-P, et al. Comparison of fesoterodine and tolterodine in patients with overactive bladder. BJU Int 2008; 102(9): 1128–32PubMedCrossRefGoogle Scholar
  20. 20.
    Data on file, Pfizer, 2009Google Scholar

Copyright information

© Adis Data Information BV 2009

Authors and Affiliations

  1. 1.Wolters Kluwer Health ¦ AdisMairangi Bay, North Shore, AucklandNew Zealand
  2. 2.Wolters Kluwer HealthPhiladelphiaUSA

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