Botox onabotulinumtoxinA: Phase III data
Top-line data from a double-blind, international Phase III trial in 548 patients showed that 100U Botox met the primary endpoint of reducing the number of daily urinary incontinence episodes from baseline to week 12 vs. placebo (3 vs. 1 episode, p<0.001). Botox also met the co-primary endpoint of a greater proportion of patients reporting a positive treatment benefit on the TBS at week 12 vs. placebo (p<0.001). Allergan said the daily urinary incontinence episodes endpoint is required in both the U.S. and Europe, whereas the TBS endpoint is only required in Europe. Additionally, Botox significantly improved mean I-QOL scores from baseline to week 12 vs. placebo (p<0.001). Botox was well tolerated with adverse events primarily limited to the urinary tract. Rates of urinary tract infection and urinary retention were 20.4% and 5.2% in patients receiving Botox, respectively, vs. 5.2% and 0.4% for placebo. Based on the results, Allergan said it submitted an sBLA to FDA in the U.S. and a regulatory application in Europe for Botox to treat OAB with symptoms of urinary incontinence, urgency and frequency in adults who have had an inadequate response to or are intolerant to anticholinergic drugs. ...