Indevus says its once-daily overactive bladder therapy Sanctura XR (trospium) will offer an advantage in terms of dry mouth, the most common side effect from OAB therapy.

The firm announced positive results June 15 from the first of two Phase III trials of the extended-release version of twice-daily Sanctura, which was approved in May 2004.

Immediate-release Sanctura has "a low incidence of dry mouth, about 20%, dry mouth being the most common and troubling side effect experienced by patients treated for OAB," Indevus CEO Glenn Cooper said in a corresponding conference call.

The 601-patient, placebo-controlled, 12-week trial of Sanctura XR reported an 8.7% incidence of dry mouth in the treatment arm, compared with 3% for placebo.

The study also met its primary endpoints of reduction in frequency of urination and reduction in number of urge incontinent episodes.

Patients enrolled in the trial reported urinary frequency of 10 or more toilet voids per day at baseline. At 12 weeks, Sanctura XR patients had 2.81 fewer toilet voids per day compared to baseline, while the placebo group reported a 1.99 drop in toilet voids.

Also, Sanctura XR patients had a 78% median reduction in the number of incontinence episodes per day, compared with 56% of placebo patients.

Cooper explained that in selling Sanctura, "the biggest disadvantage we've had to overcome in the marketplace is the fact that Sanctura is a twice-a-day drug in a category that is dominated by once-daily competitors." Sanctura is marketed by Esprit.

The goal of the study was "to provide once-daily convenience with at least comparable efficacy and tolerability to the twice-a-day drug."

At the Goldman Sachs Global Healthcare Conference June 13, Novartis Head of Pharmaceutical Development James Shannon said that rapid uptake of newer incontinence agents has been slowed by public perception regarding efficacy, as manufacturers have highlighted their safety and convenience (¹ Also see "Market Uptake Of New Incontinence Agents Impeded By Efficacy Perceptions, Novartis Says" - Pink Sheet, 14 June, 2006.).

The new formulation of Sanctura could follow the original by roughly three years; the firm expects to submit the NDA for Sanctura XR by year-end, with a launch in 2007 (² Also see "Indevus Sanctura XR To Begin Phase III Trials “Shortly”" - Pink Sheet, 9 August, 2005.).

Results of the second Phase III study are due in July.

-Kathleen Michael

Sanctura XR Could Quench Indevus’ Thirst For Once-Daily Incontinence Therapy

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