An Overview of Clinical Trial Data on a New Formulation of Botulinum Neurotoxin Type A

According to the American Society for Aesthetic Plastic Surgery, the number of aesthetic procedures involving botulinum neurotoxin type A (BoNT-A) increased 3681% between 1997 and 2008. Almost 2.5 million procedures were performed using this neurotoxin last year, accounting for approximately 25% of all nonsurgical aesthetic procedures performed in 2008.1 Both aesthetic and therapeutic uses of this neurotoxin are likely to increase in the coming years.In 2009, a new US formulation of BoNT-A (BoNTA-ABO; Dysport [abobotulinumtoxinA]; Medicis Aesthetics, Scottsdale, AZ) was approved by the US Food and Drug Administration (FDA) for the treatment of moderate to severe glabellar lines. Key features of this new BoNT-A formulation are shown in the Table.2 Outside of North America, Dysport has been used for therapeutic applications since 1991 and for aesthetic applications since 2001. Before receiving FDA approval, BoNTA-ABO had been studied in the United States under the proposed trade name Reloxin . At the time of approval, the FDA required Medicis to retain the Dysport name.View this table:Table Characteristics of Dysport in the treatment of moderate to severe glabellar lines2Several reports of pivotal US trial data regarding the safety and efficacy of this agent in patients with moderate to severe glabellar lines have been published recently in major journals.3–7 This supplement provides an up-to-date and comprehensive overview of the safety, efficacy, immunogenicity, and manufacturing of this new US botulinum neurotoxin formulation.Food poisoning by Clostridium botulinum neurotoxin has probably been a cause of death since humans first began storing food.8 C botulinum is a Gram-positive, anaerobic bacteria that is categorized on the basis of the toxins it secretes. Of the eight known …