On April 15, 2002, the US Food and Drug Administration (FDA) approved Allergan, Inc.'s Botox Cosmetic* (botulinum toxin type A) for “temporary improvement in the appearance of moderate-to-severe glabellar lines in adult men and women 65 or younger.” This was the first elective cosmetic indication for which any commercially available botulinum toxin on the US market had been approved.
The toxin had previously been approved and was marketed as Botox® for the treatment of strabismus, blepharospasm, and cervical dystonia but existing off-label cosmetic use of the toxin had already propelled annual sales to $250 million per year in 2002. With FDA recognition of the cosmetic indication, sales of both Botox® and Botox Cosmetic® surpassed $1 billion per year by the end of 2009.
The commercial introduction of Allergan's product into the US market has given unprecedented brand name equity to the drug, surpassed only by Pfizer's product Viagra® (sildenafil citrate). Botox has passed into vernacular usage as a trademark used to loosely refer to a class of biologic neurotoxins in the manner of other well-known trademarks such as Coke® and Kleenex®. The clinical utility of the neurotoxin is so widely known today that the word Botox has become a generic term in the public mind for all agents used in cosmetic neurotoxin therapy, although the term is properly reserved for Allergan's trademarked commercial version of the type A neurotoxin complex.
In April 2009, the FDA approved a third commercial neurotoxin, a serotype A product, Dysport® (Ipsen [UK]/Medicis [US]) to join Allergan's Botox®/Botox® Cosmetic and a previously approved serotype B product, Myobloc® (Solstice Neurosciences [US]). In July 2011, the FDA approved a fourth commercial neurotoxin for the US market, a serotype A product, Xeomin® (Merz Pharma GmbH [Germany]). To emphasize the noninterchangeability of these biological toxins, the FDA in August 2009 required the manufacturers to adopt new drug names: onabotulinum toxin A (Botox®/Botox® Cosmetic), abobotulinum toxin A (Dysport®), rimabotulinum toxin B (Myobloc®), and incobotulinum toxin A (Xeomin®).
One other commercial serotype A toxins is presently awaiting FDA approval: PurTox® (Mentor [US]). There are at least two other commercial serotype A toxins in use outside of the United States: Meditoxin®/Neuronox® (Medy-Tox [Korea]) and Hengli®/Prosigne® (Lanzhou [China]). Presumably the FDA will supply new drug names for these products when and if they complete the approval process.
*It is the editors’ policy not to use trade names in this book. However, in certain instances, the editors had to depart from this policy to avoid confusion.
The medical history of botulinum toxin dates back to the Holy Roman Empire at the beginning of the nineteenth century in central Europe. The Napoleonic wars eroded rural hygiene and spread poverty throughout what is now southern ...