Allergan has obtained FDA approval for Botox (onabotulinumtoxinA) to treat overactive bladder (OAB) in adults who cannot tolerate or respond poorly to anticholinergic medication.
Botox works by blocking the transmission of nerve impulses to the bladder muscle and temporarily calming muscle contractions, thereby relieving from OAB symptoms such as urge urinary incontinence, urgency and frequency.
Allergan research and development executive vice president and chief scientific officer Dr Scott Whitcup said the approval means that Botox is now cleared for 26 different indications in more than 85 countries.
"Most importantly, today's FDA approval is a milestone in the treatment of this burdensome condition and will provide a novel option for urologists and their OAB patients," Whitcup said.
The approval was based on two double-blind, randomised studies, conducted in adults with OAB that had not been managed with anticholinergic treatments, in which Botox demonstrated efficacy in reducing urinary leakage episodes.
Botox reduced daily urinary incontinence episodes by 50% or more by week 12 of the 24-week studies, as compared to placebo.
NYU Langone Medical Center female pelvic medicine and reconstructive surgery director and department of urology vice chairman Dr Victor Nitti said; "With the approval of Botox we have a new treatment option to offer these patients that has demonstrated efficacy in reducing urinary leakage and other symptoms of OAB with the effect lasting up to six months."
Botox is formulated with highly purified botulinum toxin protein, developed from Clostridium botulinum, stabilised by auxiliary proteins.
Image: Allergan, which is headquartered in Irvine, California, has received Botox approvals for 26 different indications. Photo: courtesy of Coolcaesar.