The urinary incontinence market could see the next wave of anticholinergic agents in 2003, with recent NDA submissions for two highly selective muscarinic receptor antagonists: Pfizer's darifenacin and Yamanouchi's solifenacin (YM-905).

Both agents have shown greater selectivity for M3 receptor antagonists and selectivity for bladder tissue, giving them the potential for fewer side effects than non-selective agents.

Pharmacia's Detrol and Detrol LA (tolterodine) and Alza's Ditropan and Ditropan XL (oxybutynin) currently dominate the UI market but cause a variety of side effects, such as dry mouth and tachycardia.

Pharmacia has been able to capitalize on tolterodine's safety advantages over oxybutynin to build Detrol/Detrol LA into the market leader, with worldwide sales of $757 mil. in 2002. Detrol has a lower incidence of dry mouth, which is thought to possibly result from an affinity for M2 receptors.

Pfizer is expected to have to divest darifenacin under the FTC's review of its merger with Pharmacia. If forced to divest darifenacin, Pfizer may wind up marketing Detrol against a compound it developed as a "best-in-class" treatment.

The darifenacin NDA was filed in early December 2002. Pfizer has not released clinical data so far but will likely present results at the European Urological Association annual meeting in March and the American Urological Association in April.

Yamanouchi submitted an NDA for solifenacin Dec. 19, 2002 for the relief of symptoms of urinary frequency, incontinence and urgency associated with overactive bladder. The NDA includes four placebo-controlled efficacy studies. Yamanouchi plans to present clinical data at the EUA and AUA meetings.

Watson's Oxytrol could also enter the UI market in 2003; FDA's user fee goal for the oxybutynin patch is Feb. 28. The firm is planning for a second-quarter launch (¹ Also see "Watson Oxytrol Launch To Focus On Specialists; CSO To Target Primary Care" - Pink Sheet, 27 January, 2003.).

[Editors' note: The February issue of F-D-C Reports' Pharmaceutical Approvals Monthly contains more information on recent NDA submissions. Sample copies are available; contact Dzidra Vizbulis at (800) 332-1370.]

Pfizer Darifenacin, Yamanouchi NDAs Filed For Urinary Incontinence

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