Ipsen has announced positive results from its phase IIa clinical trial assessing Dysport in the treatment of neurogenic detrusor overactivity ( NDO ) in patients with urinary incontinence not adequately managed by anticholinergics.
The results have shown that treatment with Dysport was associated with a mean reduction from baseline of urinary incontinence episodes greater than 75%, 12 weeks after the injection, regardless of how the drug is administered.
These results were achieved with a single dose of Dysport 750 units injected in either 15 or 30 sites in the detrusor muscle. Efficacy was confirmed by improvement in urodynamic parameters and quality of life. The safety profile observed in the study is consistent with the safety profile expected in this indication.
Dysport is an injectable form of Botulinum toxin type A ( BTX-A ), which is isolated and purified from Clostridium BTX-A bacteria. It is formulated as a complex of BTX-A with haemagglutinin, a large therapeutically inert protein used to stabilise the toxin. Dysport is formulated with lactose ( Ph Eur/NF ) and human serum albumin ( Ph Eur/USP ) and is supplied as a lyophilised powder.
Dysport was first registered for the treatment of blepharospasm and hemifacial spasm in the United Kingdom ( UK ) in 1990, and is licensed in more than 75 countries for various indications including: blepharospasm, adult upper and lower limb spasticity, hemifacial spasm, spasmodic torticollis ( ST ) ( previously referred to as cervical dystonia ), paediatric spasticity due to cerebral palsy ( CP ), axillary hyperhidrosis, and glabellar lines.
Dysport is not currently approved in any country for the treatment of NDO.
Neurogenic detrusor overactivity is a chronic condition defined by abnormal bladder contractions related to an underlying neurological condition such as multiple sclerosis or spinal cord injury. Current standard of care includes self-catheterisation or oral anticholinergic medications that present frequent side-effects and insufficient efficacy on the long term. In case of inadequate treatment response to anticholinergics, a botulinum toxin-A is indicated, before considering rescue treatments such as neuromodulation or bladder augmentation surgery in refractory cases. ( Xagena )
Source: Ipsen, 2014