The median duration for efficacy with BOTOX® at reducing urinary leakage and other symptoms of OAB in the two clinical studies was 135-168 days compared to 88-92 days with placebo based on qualification for retreatment. To qualify for retreatment, at least 12 weeks must have passed since the prior treatment, post-void residual urine volume must have been less than 200 mL and patients must have reported at least two urinary incontinence episodes over three days. BOTOX® treatment relieves OAB symptoms by temporarily calming muscle contractions by blocking the transmission of nerve impulses to the bladder muscle.OAB Clinical Development ProgramThe FDA approval of BOTOX® was based on safety and efficacy data from two double-blind, randomized, multi-center, placebo-controlled 24-week clinical studies of 1,105 adult patients whose OAB symptoms had not been adequately managed with anticholinergic therapy, either due to lack of efficacy or intolerance of the medication. To qualify for the study, patients had to have symptoms of OAB with symptoms of urge urinary incontinence, urgency and frequency, and experience a minimum of three urinary urgency leakage (incontinence) episodes and at least 24 urination episodes (micturitions) over a three-day timeframe. Patients in the studies were randomized to receive physician-administered treatment with 100 units of BOTOX® neurotoxin (n=557) or placebo (n=548) injected directly into the detrusor (bladder) muscle. Patients were treated in the physician’s office and received a local anesthetic, with or without sedation, to numb the bladder prior to treatment with BOTOX® or placebo.
BOTOX(R) (onabotulinumtoxinA) Receives U.S. Food And Drug Administration Approval For The Treatment Of Overactive Bladder For Adults Who Have An Inadequate Response To Or Are Intolerant Of An Anticholinergic Medication
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