Botox continues to be one of the top non-surgical (really minimally invasive) cosmetic procedures. In combination with injectable fillers, a whole new area of cosmetic improvements has been made possible. While Botox dominated the cosmetic neuromuscular market for almost a decade, its success was certain to lead to competition. Such was the case in the summer of 2009 when Dysport received FDA approval in the United States for cosmetic applications. Now we have both Botox and Dysport available although the battle is shaping up to be more like Coke and Pepsi. It is likely that Botox will dominate the market for the foreseeable future until…a competitor comes along that offers a neuromuscular product which is either substantially cheaper or lasts longer.
Interestingly, last week Merz Pharmaceuticals announced that it has received FDA approval for its botulinum toxin product, Xeomin. (technically incobotulinum toxin A) It is only currently approved for the treatment of adults with blepharospasm or cervical dystonia. To some, those applications may seem obscure but that is exactly what Botox was initially approved for way back in the 1990s. While this drug is not yet approved for cosmetic facial use, there is no doubt that is in the manufacturer’s plan in the future as soon as possible.
The results from the reported clinical trials for the use of Xeomin were in adult patients diagnosed with either cervical dystonia or blepharospasm. Other comparison studies with Botox showed that it had a similar effectiveness and side effect profile for these applications.
Like Botox, Xeomin is an injection that blocks the transmission of nerve pulses into the muscle. But it appears to have some pharmacological differences. It is reported to have increased biological activity which may or may not mean that it is more effective at lower doses. It has less ancillary proteins, so it is more pure, and thus may be less prone to develop drug resistance.The drug also does not need to be refrigerated unlike Botox and Dysport. That is only a minor benefit to the injector but a major one to the manufacturer due to shipping issues.
The key questions as they relate cosmetic use is how does Xeomin compare to Botox and Dysport in effectiveness and cost. While no clinical studies have yet been reported, every indication is that the onset of the effects is the same (one week) and its length of action is similar. (3 to 6 months) Its cost is not presently known so the idea that it may be less expensive is theoretical and likely over optimistic.
Early evidence suggests that Xeomin is going down the Dysport road…an alternative to Botox without appreciable upfront differences to the consumer. While it is not FDA-approved for cosmetic use, it will no doubt be used off-label long before it ever receives that blessing.
The manufacturer, Merz, is adopting a market strategy similar to its competitors. It has acquired Bioform Medical, the manufacturer of the injectable facial filler Radiesse. As a company it is key to have a dual cosmetic injection approach, a neuromuscular paralyzer and a volume filler. Merz appears poised to make its entrance into the cosmetic marketplace.
Dr. Barry Eppley
Indianapolis, Indiana