EWING, N.J.--(BUSINESS WIRE)--Antares Pharma, Inc. (AMEX:AIS) announced that the first patients have been dosed in the pivotal trial designed to evaluate efficacy of ANTUROL when administered topically once daily for 12 weeks in patients predominantly with urge incontinence episodes. The randomized, double-blind, parallel, placebo controlled, multi-center trial is expected to involve 600 patients (200 per arm) using two dose strengths (selected from the Phase II clinical trial) vs. a placebo. The primary end point of the trial will be efficacy against the placebo defined as the reduction in the number of urinary incontinence episodes experienced. Secondary end points include changes from baseline in urinary urgency, average daily urinary frequency, patient perceptions as well as safety and tolerability including skin irritation.
