AIS reports positive results from Anturol Gel Phase 3 study

by Zagros on July 28, 2020

Antares Pharma reports positive results from Anturol Gel Phase 3 study in overactive bladder patients

Antares Pharma, Inc. (NYSE Amex:AIS) announced today positive results from its Phase 3 study of AnturolTM Gel in patients with overactive bladder (OAB). The study met its primary endpoint of a statistically significant reduction in urinary incontinence episodes for both doses studied.

The Phase 3 trial conducted under a Special Protocol Assessment (SPA) with FDA was a double blind, randomized, parallel placebo-controlled multi-center study and evaluated the efficacy and safety of Anturol in 600 patients with overactive bladder. The primary objective of the study was to demonstrate that daily treatment of an 84mg or 56mg dose of oxybutynin applied in the ATDTM Gel technology for 12 weeks was superior to placebo for the relief of OAB symptoms.

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