Ipsen receives positive opinion in Europe for Dysport® in the management of urinary incontinence in adults with neurogenic detrusor overactivity due to Multiple Sclerosis or Spinal Cord Injury
- Submission based on data from the pivotal international Phase III CONTENT clinical programme, also recently published in European Urology1
- CONTENT showed that Dysport® decreased incontinence episodes, detrusor pressure and increased bladder capacity versus placebo, and improved quality of life1
Ipsen announced on June 9th 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 catheterisation (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® is an injectable form of a botulinum neurotoxin type A (BoNT-A) product, which has previously shown clinically meaningful benefit in the symptomatic treatment of focal spasticity and cervical dystonia.
1. Kennelly M et al., Efficacy and Safety of AbobotulinumtoxinA in Patients with Neurogenic Detrusor Overactivity Incontinence Performing Regular Clean Intermittent Catheterization: Pooled Results from Two Phase 3 Randomized Studies (CONTENT1 and CONTENT2). European Urology. 2022; S0302-2838(22)01680–3
2. Mehnert U, et al., The Management of Urine Storage Dysfunction in the Neurological Patient. SN Comprehensive Clinical Medicine. 2019; 1:160–182
3. Alsulihem A and Corcos J. Evaluation, treatment, and surveillance of neurogenic detrusor overactivity in spinal cord injury patients. Neuroimmunol Neuroinflammation. 2019; 6:13
4. Ginsberg, D. The Epidemiology and Pathophysiology of Neurogenic Bladder. Am J Manag Care. 2013; 19(10)191–6