Sanctura Once-Daily NDA Touts “Landmark Tolerability”
This article was originally published in The Pink Sheet Daily
Executive Summary
Indevus will position the XR version of its incontinence therapy based on its low incidence of dry mouth.
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Indevus Pharmaceuticals announced Oct. 12 that it has filed an NDA for the once-daily form of its incontinence therapy Sanctura (trospium). The filing "is a very important milestone for the company. We believe that the overall efficacy and landmark tolerability of Sanctura XR will enable us to strongly position [the product] in the overactive bladder market," said Indevus CEO Glenn Cooper. Sanctura XR "set a new tolerability benchmark for oral drugs in the treatment of overactive bladder with an overall dry mouth incidence of 10.7% in the Phase III trials," the Lexington, Mass.-based company said. In addition, "Sanctura XR retains the unique attributes of Sanctura, including a low incidence of [central nervous system] side effects, lack of metabolic drug-drug interactions and a rapid onset of action." The company reported positive results from two Phase III trials conducted for Sanctura XR in overactive bladder this summer (1 (Also see "Sanctura XR NDA Filing On Target For Year-End" - Pink Sheet, 10 Jul, 2006.)). Sanctura XR will compete with extended-release forms of Johnson & Johnson's Ditropan XL (oxybutynin), Pfizer's Detrol LA (tolterodine) and Watson's oxybutynin patch Oxytrol . Other overactive bladder drugs on the market are GlaxoSmithKline/Astellas' Vesicare (solifenacin) and Novartis/Procter & Gamble's Enablex (darifenacin), approved in 2004 along with Sanctura (2 (Also see "P&G Joins Novartis’ Efforts To Market Overactive Bladder Treatment Enablex" - Pink Sheet, 6 Jul, 2005.)). - Shirley Haley ([email protected]) |