Oxybutynin chloride topical gel: a new formulation of an established antimuscarinic therapy for overactive bladder

Expert Opin Pharmacother. 2009 Dec;10(18):3103-11. doi: 10.1517/14656560903451682.

Abstract

Background: Oxybutynin, a cholinergic-muscarinic receptor antagonist, is established as a safe and effective pharmacological treatment for patients with overactive bladder syndrome (OAB). Oxybutynin is available in multiple immediate- and extended-release oral and two transdermal formulations. Oxybutynin chloride topical gel (OTG) (Gelnique), Watson Pharmaceuticals, Corona, CA, USA) was approved in January 2009 by the US FDA. OTG was designed to provide consistent plasma oxybutynin levels with daily application, favorably altering the circulating N-desethyloxybutynin metabolite:oxybutynin ratio, and to utilize a biocompatible delivery system, thus minimizing both the anticholinergic adverse effects of oral formulations and the application-site skin reactions associated with other available forms of transdermal delivery.

Objective/methods: This review summarizes the pharmacological properties and the clinical efficacy and safety profile of OTG based on the published literature and unpublished data provided by the manufacturer upon request.

Results/conclusion: OTG represents an efficacious, safe, and convenient alternative to other oxybutynin formulations and other oral anticholinergic medications for the treatment of OAB. Future studies and broad clinical experience should confirm the promising early experience observed with this formulation.

Publication types

  • Research Support, Non-U.S. Gov't
  • Review

MeSH terms

  • Administration, Cutaneous
  • Chemistry, Pharmaceutical
  • Clinical Trials, Phase III as Topic
  • Gels
  • Humans
  • Mandelic Acids* / administration & dosage
  • Mandelic Acids* / adverse effects
  • Mandelic Acids* / pharmacology
  • Mandelic Acids* / therapeutic use
  • Muscarinic Antagonists* / administration & dosage
  • Muscarinic Antagonists* / adverse effects
  • Muscarinic Antagonists* / pharmacology
  • Muscarinic Antagonists* / therapeutic use
  • Treatment Outcome
  • Urinary Bladder, Overactive / drug therapy*

Substances

  • Gels
  • Mandelic Acids
  • Muscarinic Antagonists
  • oxybutynin