Solesta: Pivotal trial data

A double-blind, international pivotal trial in 206 patients showed that transanal submucosal injections of Solesta met the primary endpoint of response to treatment as measured by a significantly greater proportion of patients with a >=50% reduction from baseline in the number of incontinence episodes over 6 months vs. sham control (52% vs. 31%, p=0.0089). Solesta also met the secondary endpoint of significantly increasing the mean number of incontinence-free days at 6 months vs. sham control (3.1 vs. 1.7 days, p=0.0156), but missed the endpoint at 3 months (2.6 vs. 1.9, p=0.188). Additionally, Solesta missed the secondary endpoint of significantly reducing the median number of incontinence episodes from baseline at both 3 (4.8 vs. 3, p=0.14) and 6 months (6 vs. 3, p=0.09) vs. sham control. After 6 months, patients in the sham control group were eligible to receive open-label Solesta. Data were published in The Lancet. ...