Investigational OAB agent shows significant improvements in phase III trial

An agent under investigation for treatment of overactive bladder demonstrated statistically significant improvements over placebo in phase III trials, according to Schwarz Pharma, which is developing the drug, fesoterodine.

The double-blind, placebo-controlled studies included 1,900 U.S. and European patients who were randomized and began a 2-week placebo run-in phase followed by a 12-week treatment period. Patients received placebo or fesoterodine, 4 mg or 8 mg once daily.

Researchers said there were improvements in all primary variables, including:

• change in average number of micturitions per 24 hours
  

• change in average number of urge incontinence episodes per 24 hours
  

• treatment response, derived from a Treatment Benefit Scale.

Schwarz said the study results enable the company to prepare applications for marketing authorizations with U.S. and European regulatory authorities.