Company submits NDA for once-daily OAB drug
Indevus Pharmaceuticals, Inc. has submitted a new drug application to the FDA seeking approval for a once-daily formulation of trospium chloride (Sanctura XR) to treat patients with overactive bladder.
Indevus Pharmaceuticals, Inc. has submitted a new drug application to the FDA seeking approval for a once-daily formulation of trospium chloride (Sanctura XR) to treat patients with overactive bladder.
The NDA submission follows the June and July 2006 announcements of positive results from two phase III trials conducted for the drug in overactive bladder. Both trials met their primary endpoints and key secondary endpoints, Indevus reported. In addition, the company said it believes that once-daily trospium has 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.
In one phase III trial, patients treated with once-daily trospium experienced statistically significant (p<.0001) improvement in number of toilet voids per day after 12 weeks compared with patients on placebo. At week 12, patients receiving the drug had 2.7 fewer toilet voids per day compared with baseline, and placebo patients had 1.9 fewer toilet voids per day compared with baseline.
