Allergan received U.K. regulatory clearance for the use of Botox® in the management of urinary incontinence in adult patients with neurogenic detrusor overactivity (NDO) caused by nontraumatic or traumatic subcervical spinal cord injury (SCI), or multiple sclerosis (MS), who aren’t adequately managed using anticholinergics. The marketing authorization is specific for Allergan’s botulinum toxin type A product.
U.K. clearance was based on data from two Phase III trials in Allergan’s Dignity program, which included nearly 700 patients with either SCI or MS. Participants received a single cystoscope-administered injecton of either placebo or Botox into the detrusor muscle. The results showed that treatment with Botox was effective within two weeks, and lasted for about nine months. More specifically, 76% of patients treated with Botox exhibited a 50% or more reduction in urinary wetting episodes by week six, and nearly 40% of patients were completely dry during week six, compared with 9% of placebo patients.
“Historically, the management of urinary incontinence due to NDO has relied on daily medications,” explains Christopher Chapple, M.D., at the Royal Hallamshire Hospital in the U.K., who acted as one of the key investigators in the registrational trials. “However, many patients find that daily medications are difficult to adhere to and sometimes these medications have limited effect. Now, Botox injections, given every 8-10 months into the bladder, means that I have a new and potentially life-changing treatment to help patients get this distressing condition under control.”