EU gives positive opinion on Dysport in urinary incontinence.
Ipsen announced that Dysport (abobotulinumtoxinA) has received positive opinion in Europe for the management of urinary incontinence (UI) in adults with neurogenic detrusor overactivity (NDO) due to spinal cord injury (SCI) (traumatic or non-traumatic) or multiple sclerosis (MS), who are regularly performing clean intermittent catheterization (CIC).
This positive opinion for Dysport now permits individual European country Health Authorities to grant national approvals, according to their country regulations. In addition, Ipsen is also currently in the process of obtaining approvals in other countries outside the European Union.
Dysport was assessed in CONTENT, a large, international, Phase III clinical program. The CONTENT1 and CONTENT2 Phase III trials included 485 patients living with NDO and UI who were regularly undergoing CIC and inadequately managed by oral therapy. Patients recorded the number of UI episodes they experienced per day over a 7-day period in an eDiary at baseline and at weeks 2, 6, and 12, and every 12 weeks thereafter. The volume per void during a 24-hour period was also recorded in the eDiary.
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