First Approval For P&U's Detrusitol For Incontinence

Pharmacia & Upjohn has been granted its first marketing approval, inSweden, for Detrusitol (tolterodine), a new treatment for urinary incontinence. Sweden is acting as the rapporteur country for the European Union's mutual recognition system.

P&U plans to begin the launch of Detrusitol in all the major markets where it has been approved beginning next year, so its impact on the firm's financial performance will not occur during 1997. The dossier for the drug has also been filed in the USA.

Detrusitol was developed specifically as a treatment for unstable bladder, a cause of urinary incontinence, and offers equivalent efficacy and safety but greater tolerability than oxybutynin, currently the most widely-used drug for this condition. Specifically, Detrusitol is associated with a significantly lower rate of dry mouth than oxybutynin, according to the results of four comparative Phase III studies conducted by P&U (see table). In these studies, Detrusitol at two doses (1mg/day and 2mg/day) was compared to oxybutynin 5mg/day and placebo in 1,120 patients (the 1mg Detrusitol dose was not as effective as the 2mg dose).