Solabegron: Phase II data

A double-blind, international Phase II trial in 258 women with moderate to severe OAB symptoms showed that twice-daily 125 mg solabegron met the primary endpoint of reducing the mean number of incontinence episodes per 24 hours from baseline to week 8 vs. placebo. Specifically, solabegron led to a 65.6% mean reduction from baseline in incontinence episodes and an adjusted mean reduction from placebo of 21% (p=0.025). The twice-daily 50 mg dose missed the endpoint. On secondary endpoints, low- and high-dose solabegron led to significant adjusted mean reductions from placebo in the number of incontinence episodes per 24 hours from baseline to week 4 of 23% and 32%, respectively. (p=0.03 and p=0.003). High-dose solabegron also significantly reduced the frequency of urinations per day at weeks 4 (p=0.05) and 8 (p=0.036) vs. placebo, and significantly increased the volume of urine voided per urination by 27% at week 8 vs. placebo (p<0.001). Solabegron was well tolerated with headache and nasopharyngitis reported as the most frequent adverse events. Data were presented at the European Association of Urology Congress in Paris. ...