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news.Allergan has received the US Food and Drug Administration (FDA) approval for prescription-only Botox (onabotulinumtoxinA) for injection to treat urinary incontinence in patients with multiple sclerosis (MS) or spinal cord injury (SCI).
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Botox is indicated as a treatment for urinary incontinence due to detrusor overactivity linked with a neurologic condition like, SCI, MS in adults patients who have an inadequate response to or are intolerant of an anticholinergic medication.
Results from the two Phase III clinical trials demonstrated reductions in the frequency of urinary incontinence episodes in patients treated with 200 Units of Botox neurotoxin compared to placebo within two weeks and approximately 20 fewer urinary incontinence episodes at week six versus placebo.
Allergan R&D executive vice president and chief scientific officer Scott Whitcup said Botox is the first neurotoxin to undergo formal clinical evaluation and receive FDA approval for a urological indication.