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Medical Areas: Nephrology
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Sanctura (trospium chloride)
The following drug information is obtained from various newswires, published
medical journal articles, and medical conference presentations.
Company: Indevus Pharmaceuticals
Approval Status: Approved May, 2004
Treatment Area: Overactive bladder
Sanctura oral tablets contain trospium, an antimuscarinic
antispasmodic agent. Antimuscarinic agents act as
parasympathetolytics in muscular tissues, and has been shown to
reduce the tonus (elastic tension) of smooth muscles of the
It is specifically indicated for the treatment of
overactive bladder with symptoms of urge
urinary incontinence, urgency, and urinary frequency.
Sanctura is administered via oral tablets of 20 mg twice daily,
with a possible reduction in dosage, to 20 mg once daily, in the
elderly and in subjects with renal impairment. Dosing should occur
at least 1 hour prior to meal times.
FDA approval of Sanctura was based upon two 12 week,
double-blind, placebo controlled studies. The first study enrolled
a total of 523 subjects with urge or mixed (predominantly urge)
incontinence, with >70 micturitions and >7 urge incontinence
episodes per week. Subjects received either 20 mg. Sanctura (n=262)
or placebo (n=261) twice daily for 12 weeks. Subjects receiving
Sanctura were shown to have significantly fewer micturitions per
day (p < 0.001), significantly fewer urge incontinence episodes
per week (p = 0.012), and significantly greater void volume per
micturition (p < 0.001). The second trial, which enrolled 658
subjects (329 Sanctura, 329 placebo), consistently confirmed the
results of the first.
Adverse events associated with the use of Sanctura may include,
but are not limited to, the following:
- Dry mouth
In addition, angioneurotic edema was observed in one subject
during clinical investigation; it is has not been determined if
this reaction represents a clinically relevant event.
Mechanism of Action
Trospium chloride acts as a direct antagonist at muscarinic
acetylcholine receptors in cholinergically innervated organs. It
has been shown to have negligible affinity for nicotinic
acteylcholine receptors at therapeutic doses, and to not easily
cross the blood-brain barrier, yielding a localized, potent
anticholinergic for peripheral targets. Its
anticholinergic-parasympatholytic action reduces the tonus of
smooth muscle in the bladder, effectively reducing the number of
required voids, urge incontinence episodes, urge severity and
improving retention, facilitating increased volume per void.
Zinner N, Gittelman M, Harris R, Susset J, Kanelos A,
Auerbach S; Trospium Study Group. Trospium chloride
improves overactive bladder symptoms: a multicenter phase III
trial. Journal of Urology. 2004 Jun;171(6 Pt 1):2311-5,
Guay DR. Clinical pharmacokinetics of drugs
used to treat urge incontinence. Clinical
Pharmacokinetics. 2003;42(14):1243-85. Review.
Hay-Smith J, Herbison P, Ellis G, Moore K.
Anticholinergic drugs versus placebo for overactive bladder
syndrome in adults. Cochrane Database of Systematic
Reviews 2002;(3):CD003781. Review.
For additional information regarding Sanctura or overactive
bladder, please contact the Sanctura Web Site