Allergan says that Botox, best-known as a treatment for wrinkles, is on the verge of being approved in Europe to help bladder control.
Botox (botulinum toxin type A) has received a positive opinion from the Irish Medicines Board for the treatment of idiopathic overactive bladder (OAB) with symptoms of urinary incontinence, urgency and frequency in adults who have an inadequate response to, or are intolerant of, anticholinergic medications. Ireland has served as the reference member state in the European mutual recognition procedure for 13 other countries - Austria, Belgium, Denmark, Finland, Germany, Greece, Iceland, Italy, Luxemburg, Norway, Portugal, Spain and Sweden.
The positive opinion is based on the results of two Phase III trials involving over 1,100 patients. In these studies, patients who received targeted injections of Botox into the bladder muscle experienced a significant and clinically relevant response to treatment compared to placebo.
Allergan noted that idiopathic OAB is "surprisingly common in Europe", with studies indicating that up to 16.6% of the population may have the condition. Of these, up to 36% will experience urinary incontinence associated with urgency and the company added that research indicates more than 50% of patients stop taking at least one oral medication within 12 months, likely due to lack of efficacy or side-effects.
Douglas Ingram, president of Allergan in Europe, Africa and the Middle East, said that gaining effective control over their bladder without the fear of leakage after only one treatment can be a significant step towards improving quality of life for patients. He added that “this is a critical milestone for the organisation, extending our commitment to urology beyond neurogenic detrusor overactivity and building on our long-term commitment to innovation in botulinum toxin research".
As well as being a wrinkle smoother, Botox is also used for a number of other indications, including chronic migraine, certain facial spasms, cervical dystonia, excessive sweating of the armpits and the treatment of post-stroke spasticity in the hand and wrist.
SkinMedica acquisition done deal
Meantime, Allergan has completed its $375 million acquisition of SkinMedica, which sells a variety of 'physician dispensed' non-prescription aesthetic skin care and prescription products. Chief executive David Pyott said the SkinMedica purchase will "further strengthen our leadership position in the facial aesthetics market".
