Document Detail


Botulinum neurotoxin type A free of complexing proteins (XEOMIN) in focal dystonia.
MedLine Citation:
PMID:  17385940     Owner:  NLM     Status:  MEDLINE    
Abstract/OtherAbstract:
Botulinum neurotoxin type A (BTX-A) weakens voluntary muscle strength and is an effective therapy for focal dystonia, including cervical dystonia (CD) and benign essential blepharospasm (BEB). It is also known to relieve hemifacial spasm and focal spasticity in children and adults. In addition, BTX-A has been shown to be effective in a wide range of other indications, such as gastrointestinal disorders, hyperhidrosis and cosmetic wrinkle correction (e.g. glabellar frown lines). A new formulation of BTX-A, NT 201 (XEOMIN((R))) has been developed. NT 201 is a formulation of pure BTX-A free of complexing proteins and, therefore, may have a reduced immunogenic potential compared with other BTX-A preparations. The pre-clinical and clinical development of NT 201 is reviewed in this article.A total of five clinical trials were completed in Europe and Israel. Two studies were conducted in 46 healthy volunteers. A further three studies in 816 patients were conducted to provide data on the safety and efficacy of NT 201 in the treatment of CD and BEB. NT 201 was found to provide non-inferior efficacy and safety profiles in the treatment of CD and BEB compared with a BTX-A preparation containing complexing proteins (BOT [BOTOX((R))]). The clinical development programme of NT 201 showed a 1 : 1 NT 201 to BOT dose ratio. The pre-clinical studies conducted with NT 201 showed an acceptable safety profile and support the use of NT 201 in an intramuscular administration regimen for patients with CD and BEB. NT 201 was effective, well tolerated and non-inferior to BOT in the treatment of both CD and BEB. In addition, there were no differences between the two therapies in terms of onset of action, duration and waning of effect. Further research is required to determine the long-term efficacy and safety profile of NT 201.
Authors:
Wolfgang H Jost; Jörg Blümel; Susanne Grafe
Publication Detail:
Type:  Journal Article; Research Support, Non-U.S. Gov't; Review    
Journal Detail:
Title:  Drugs     Volume:  67     ISSN:  0012-6667     ISO Abbreviation:  Drugs     Publication Date:  2007  
Date Detail:
Created Date:  2007-03-27     Completed Date:  2007-07-05     Revised Date:  2011-03-03    
Medline Journal Info:
Nlm Unique ID:  7600076     Medline TA:  Drugs     Country:  New Zealand    
Other Details:
Languages:  eng     Pagination:  669-83     Citation Subset:  IM    
Affiliation:
Department of Neurology and Clinical Neurophysiology, Deutsche Klinik für Diagnostik, Wiesbaden, Germany. jost.neuro@dkd-wiesbaden.de
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MeSH Terms
Descriptor/Qualifier:
Botulinum Toxins, Type A / administration & dosage,  chemistry,  therapeutic use*
Clinical Trials as Topic
Dystonic Disorders / drug therapy*
Humans
Meta-Analysis as Topic
Neurotoxins / administration & dosage,  chemistry,  therapeutic use
Chemical
Reg. No./Substance:
0/Neurotoxins; 0/incobotulinumtoxinA; EC 3.4.24.69/Botulinum Toxins, Type A

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