Comparing two botulinum toxin type A formulations using manufacturers' product summaries

J Clin Pharm Ther. 2007 Aug;32(4):387-402. doi: 10.1111/j.1365-2710.2007.00835.x.

Abstract

Background and objective: Because of the unique pharmacology and clinical versatility of botulinum toxin (BoNT), particularly BoNT serotype A (BoNTA), a need exists for discussion of the current data on similarities and differences between two BoNTA products, BOTOX and Dysport.

Methods: We compared the physiochemical and pharmacological properties of BOTOX and Dysport using information from the Summary of Product Characteristics (SmPC) documents from a number of countries around the world.

Results and discussion: Our analysis based on the SmPC documents demonstrated distinct differences in physical characteristics, breadth of approved indications, dosing and administration, and the incidence and severity of adverse events.

Conclusion: BOTOX and Dysport are not bioequivalent. Many of the differences between BOTOX and Dysport discussed within are probably related to the differences in their physical characteristics.

Publication types

  • Comparative Study
  • Research Support, Non-U.S. Gov't

MeSH terms

  • Biological Products / adverse effects
  • Biological Products / chemistry
  • Biological Products / pharmacokinetics
  • Biological Products / pharmacology
  • Botulinum Toxins, Type A / adverse effects
  • Botulinum Toxins, Type A / chemistry*
  • Botulinum Toxins, Type A / pharmacokinetics
  • Botulinum Toxins, Type A / pharmacology
  • Dose-Response Relationship, Drug
  • Drug Labeling*
  • Humans
  • Neuromuscular Agents / administration & dosage
  • Neuromuscular Agents / adverse effects
  • Neuromuscular Agents / chemistry*
  • Neuromuscular Agents / pharmacokinetics
  • Neuromuscular Agents / pharmacology
  • Therapeutic Equivalency

Substances

  • Biological Products
  • Neuromuscular Agents
  • Botulinum Toxins, Type A