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
Ipsen has received a positive opinion in Europe for Dysport® (abobotulinumtoxinA) aimed at treating urinary incontinence in adults with neurogenic detrusor overactivity due to spinal cord injury or multiple sclerosis. This approval allows individual European countries to grant national approvals. Dysport® showed significant improvements in clinical trials, reducing incontinence episodes and enhancing bladder capacity. The CONTENT Phase III trial included 485 patients and demonstrated Dysport®'s efficacy in managing symptoms inadequately controlled by oral therapies.
- Dysport® received a positive opinion in Europe for urinary incontinence treatment.
- Clinical trials demonstrated a significant decrease in incontinence episodes and increased bladder capacity.
- None.
- Submission based on data from the pivotal international Phase III CONTENT clinical program, 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
Disclaimer: Intended for international media and investor audiences only
Ipsen (Euronext: IPN; ADR: IPSEY) today announced that Dysport® (abobotulinumtoxinA) has received positive opinion in
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
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.
ENDS
About the CONTENT Phase III program
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.1
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.1
About neurogenic detrusor overactivity
Neurogenic detrusor overactivity (NDO) incontinence is a chronic condition caused by lesions of the central nervous system that result in urinary incontinence (UI).1,2
Up to
About Dysport®
Dysport® (abobotulinumtoxinA) is an injectable form of a botulinum neurotoxin type A (BoNT-A) product, which is a substance derived from Clostridium bacteria producing BoNT-A that inhibits the effective transmission of nerve impulses and thereby reduces muscular contractions. It is supplied as a lyophilized powder. AbobotulinumtoxinA has marketing authorization in more than 90 countries, more than 30 years of clinical experience and 6 million treatment years of patient experience.
The detailed recommendations for the use of Dysport are described in the Summary of Product Characteristics (SmPC) for Dysport (300 units) Powder and Dysport (500 units) Powder, and the
NOTE: Dysport® labels and approved indications may vary from country to country.
About Ipsen
Ipsen is a global, mid-sized biopharmaceutical company focused on transformative medicines in Oncology, Rare Disease and Neuroscience. With Specialty Care sales of over
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References
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
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