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 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
PARIS--(BUSINESS WIRE)--Regulatory News:
Disclaimer: Intended for international media and investor audiences only
Ipsen (Euronext: IPN; ADR: IPSEY) today 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® 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.
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 99% of patients living with MS and up to 84% of patients living with SCI suffer from NDO2,3 and it can cause a substantial impairment to quality of life, social isolation, and embarrassment.4
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 U.S. Prescribing Information (PI).
NOTE: Dysport® labels and approved indications may vary from country to country.
Ipsen is a global, mid-sized biopharmaceutical company focused on transformative medicines in Oncology, Rare Disease and Neuroscience. With Specialty Care sales of over €2.6bn in FY 2021, Ipsen sells medicines in over 100 countries. Alongside its external-innovation strategy, the Company’s research and development efforts are focused on its innovative and differentiated technological platforms located in the heart of leading biotechnological and life-science hubs: Paris-Saclay, France; Oxford, U.K.; Cambridge, U.S.; Shanghai, China. Ipsen has around 4,500 colleagues worldwide and is listed in Paris (Euronext: IPN) and in the U.S. through a Sponsored Level I American Depositary Receipt program (ADR: IPSEY). For more information, visit ipsen.com.
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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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