Second Botox Rival Joins Frown Line Market
On July 21, the Food and Drug Administration approved incobotulinumtoxinA for the temporary improvement in appearance of moderate to severe glabellar lines in adult patients.
Manufactured by Merz Aesthetics and marketed as Xeomin, incobotulinumtoxinA is the third botulinum toxin type A to enter the marketplace, following Botox and Dysport, respectively. It is expected to be available to physicians in the United States in the spring of 2012.
IncobotulinumtoxinA's approval is based on results from two clinical trials conducted at 16 sites in the United States that included 547 healthy adult patients. According to Merz, in both studies, the product significantly improved the appearance of glabellar lines 30 days after the first injection, compared with placebo.
IncobotulinumtoxinA is classified as a pregnancy category C agent and is the only botulinum toxin currently approved in the United States that does not require refrigeration prior to reconstitution.
In an interview, Dr. Joel L. Cohen, one of the trial investigators and director of AboutSkin Dermatology in Denver called incobotulinumtoxinA "more similar than it is different to other products that are on the market, particularly Botox. It’s exciting for botulinum toxin to be in the news again for something very positive in the approval of another product. I think that we should feel comfortable using Xeomin as something that has demonstrated safety and efficacy."
Dr. Christopher Zachary, professor and chair of the department of dermatology at the University of California, Irvine, predicted that Xeomin "is going to give Allergan a run for its money. The introduction of this product is likely to be more easily adopted than rival Dysport because one vial of Xeomin contains 100 units of botulinum toxin and can be diluted similarly. Dose for dose, this direct comparison with Botox is going to make staff feel quite comfortable from the get-go. Requiring staff to use different dilutions and maintain correct labeling just adds another element of confusion and might increase the potential for incorrect dosing. Having said this, Dysport remains a premier and very equivalent product and will have its devotees."