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.
Dr. Joel L. Cohen
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
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."
<a href="http://polldaddy.com/poll/5276782/" external="1">Will you treat patients with Xeomin when it becomes available?</a>According to Merz, use of the product is contraindicated "in patients with a known hypersensitivity to the active substance botulinum toxin type A or to any of the components in the formulation and in the presence of infection at the proposed injection site(s)." The company also noted that the potency units of incobotulinumtoxinA are not interchangeable with other preparations of botulinum toxin products. "Therefore, units of biological activity of Xeomin cannot be compared to or converted into units of any other botulinum toxin products."
The most common adverse reaction was headache, which was reported by 5.4% of patients in the trials.
Xeomin is approved for the temporary improvement in the appearance of glabellar lines in 14 countries in the European Union, including Germany, the United Kingdom, France, Italy and Spain, under the brand name Bocouture.
Dr. Cohen disclosed that he has been a consultant and clinical trial investigator for Merz, Allergan, and Medicis.
Dr. Zachary disclosed that he has received support and honoraria from Merz, Allergan, and Medicis for various educational courses in recent years.