Antares Pharma, Inc. Reaches Agreement with FDA on Special Protocol Assessment for Pivotal Trial of Anturol™

EWING, N.J.--(BUSINESS WIRE)--Antares Pharma (AMEX: AIS), announced that a Special Protocol Assessment has been completed with the U.S. Food and Drug Administration (FDA) for the Pivotal Efficacy Trial of Anturol for the treatment of overactive bladder. A Special Protocol Assessment documents the FDA’s agreement that the design and planned analysis of the trial adequately addresses objectives in support of a regulatory submission such as a New Drug Application (NDA). The randomized, double-blind, open-label, parallel, placebo controlled, multi-center trial will evaluate the efficacy of Anturol when administered topically once daily for 12 weeks predominantly in patients with urge incontinency episodes. The trial is expected to enroll up to 600 patients (200 per arm) using two dose strengths of Anturol (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 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.

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