title: Clinical and pharmacological properties of incobotulinumtoxinA and its use in neurological disorders.
abstract: BACKGROUND
  IncobotulinumtoxinA (Xeomin(®)) is a purified botulinum neurotoxin type A formulation, free from complexing proteins, with proven efficacy and good tolerability for the treatment of neurological conditions such as blepharospasm, cervical dystonia (CD), and post-stroke spasticity of the upper limb. This article provides a comprehensive overview of incobotulinumtoxinA based on randomized controlled trials and prospective clinical studies.
  
  
  CONCLUSIONS
  IncobotulinumtoxinA provides clinical efficacy in treating blepharospasm, CD, and upper-limb post-stroke spasticity based on randomized, double-blind, placebo-controlled trials with open-label extension periods (total study duration up to 89 weeks). Adverse events were generally mild or moderate. The most frequent adverse events, probably related to the injections, included eyelid ptosis and dry eye in the treatment of blepharospasm, dysphagia, neck pain, and muscular weakness in patients with CD, and injection site pain and muscular weakness when used for treating spasticity. In blepharospasm and CD, incobotulinumtoxinA was investigated in clinical trials permitting flexible intertreatment intervals based on the individual patient's clinical need; the safety profile of intervals shorter than 12 weeks was comparable to intervals of 12 weeks and longer. There were no cases of newly formed neutralizing antibodies during the Phase III and IV incobotulinumtoxinA trials. Phase III head-to-head trials of incobotulinumtoxinA versus onabotulinumtoxinA for the treatment of blepharospasm and CD have demonstrated therapeutic equivalence of both formulations. Additional Phase III trials of incobotulinumtoxinA in conditions such as lower-limb spasticity, spasticity in children with cerebral palsy, and sialorrhea in various neurological disorders are ongoing.
  
  
  CONCLUSIONS
  IncobotulinumtoxinA is an effective, well-tolerated botulinum neurotoxin type A formulation. Data from randomized clinical trials and further observational studies are expected to help physicians to optimize treatment by tailoring the choice of formulation, dose, and treatment intervals to the patient's clinical needs.
authors.affiliation: Department of Neurology, University of Freiburg, Freiburg, Germany.
authors.forename: Wolfgang H
authors.initials: WH
authors.lastname: Jost
authors.affiliation: Clinic and Policlinic for Neurology, University of Rostock, Rostock, Germany.
authors.forename: Reiner
authors.initials: R
authors.lastname: Benecke
authors.affiliation: Institute of Medical Biometry and Medical Informatics, University of Freiburg, Freiburg, Germany.
authors.forename: Dieter
authors.initials: D
authors.lastname: Hauschke
authors.affiliation: Department of Neurology, Baylor College of Medicine, Houston, TX, USA.
authors.forename: Joseph
authors.initials: J
authors.lastname: Jankovic
authors.affiliation: Department of Neurology, Palacky University Olomouc, Faculty of Medicine and Dentistry and University Hospital, Olomouc, Czech Republic.
authors.forename: Petr
authors.initials: P
authors.lastname: Kaňovský
authors.affiliation: University Eye Clinic of Bonn, Bonn, Germany.
authors.forename: Peter
authors.initials: P
authors.lastname: Roggenkämper
authors.affiliation: Icahn School of Medicine at Mount Sinai, New York, NY, USA.
authors.forename: David M
authors.initials: DM
authors.lastname: Simpson
authors.affiliation: Rush University Medical Center, Chicago, IL, USA.
authors.forename: Cynthia L
authors.initials: CL
authors.lastname: Comella
mesh_terms: D019274:Botulinum Toxins, Type A / Q000627:therapeutic use*; D006801:Humans; D009422:Nervous System Diseases / Q000188:drug therapy*; D016032:Randomized Controlled Trials as Topic
chemical_list: D019274:Botulinum Toxins, Type A; C545476:incobotulinumtoxinA
keywords: Xeomin; blepharospasm; botulinum toxin; cervical dystonia; incobotulinumtoxinA; spasticity