Antares Pharma, Inc. (AIS) announced the New Drug Application, or NDA, for Anturol Gel in patients with overactive bladder, or OAB, was accepted for filing for review by the U.S. Food and Drug Administration, or FDA.
Anturol is an oxybutynin gel incorporating Antares Pharma's ATD Gel technology.
The Anturol NDA submission is supported by data from a Phase 3 randomized, double-blind, placebo-controlled clinical trial involving 600 patients with OAB. In the 12-week study, patients treated with Anturol 56 mg daily or 84 mg daily experienced a significant decrease in OAB symptoms versus placebo, including the number of urinary incontinence episodes per day.
The company noted that Anturol was well tolerated in the study with no reported serious treatment-related adverse events. Anticholinergic side effects such as dry mouth and constipation were low and no increase in CNS side effects was seen compared to placebo.
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