Allergan Inc. (AGN) said that two Phase III clinical trials of BOTOX as a potential treatment option for patients with idiopathic overactive bladder met their pre-specified primary endpoints. Results from both Phase III clinical trials show that BOTOX significantly reduced urinary incontinence episodes compared to placebo for the treatment of overactive bladder patients with urinary incontinence who were not adequately managed by an anticholinergic treatment.
Based on the two Phase III clinical trials results, Allergan has submitted a supplemental biologics license application or sBLA with the U.S. Food and Drug Administration or FDA and an application with European Regulatory authorities seeking approval for the use of BOTOX as overactive bladder treatment with symptoms of urinary incontinence, urgency, and frequency, in adult patients who have an inadequate response to or are intolerant of an anticholinergic medication.
Overactive bladder or OAB is a medical condition that results in an uncontrolled urge to void, frequent voids and, in many patients, uncontrolled urinary leakages.
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