In July of 2011, the FDA approved a new brand of botulinum toxin for treating vertical brow wrinkles in adults. This cosmetic treatment (incobotulinumtoxinA) goes by the brand name Xeomin. It is manufactured in Germany by Merz Pharmaceuticals but is approved for distribution in the U.S. So far, the production process has started and the proper safety labeling on the cartons has been determined. The first shipments are expected to be available to doctors in the United States in early 2012.
Xeomin Approved for Medical & Cosmetic Use
Like other botulinum products, this one was developed for medically necessary purposes such as treating eyelid spasm or chronic neck pain. However, it has also been used in 2 clinical trials for cosmetic improvement of glabellar lines (wrinkles between the eyebrows). The product offered a noticeable minimization of frown lines compared to placebo at the 30 day mark after treatment. Since this product has basically the same active ingredient as Botox and Dysport and works in the same way by blocking nerve signals to the muscles, Xeomin moved fairly quickly through the FDA approval process.
Product Safety Profile
The company will be required to continue testing for some time to further evaluate safety in various patient groups, but the results and the overall risk profile are expected to be similar to other botulinum toxins. The protein solution which carries the toxin molecule is different in Xeomin than in Botox and is hoped to cause fewer side effects in the larger doses used to treat medical conditions. However, many dermatologists feel this change won’t have any impact when it comes to the small doses used for cosmetic treatment. The most commonly mentioned side effect among patients receiving wrinkle treatment with Xeomin was headache.
No Comparison Trials Yet Done
So far, no split face studies have been conducted in the U.S. comparing Xeomin to Botox or Dysport to determine which one is the most effective for wrinkle reduction. It’s not likely that Xeomin will provide significantly longer lasting effects than other botulinum injectables. Brow wrinkles become noticeable again as the nerves in the face repair themselves, causing the muscles to begin contracting normally and reinforcing frown lines. It’s not so much the drug “wearing off” as the body healing itself. This tends to occur at a similar rate in most people after exposure to botulinum toxin. Some patients can go longer between Botox treatments over time, but this effect varies from one individual to another. In the final analysis, the main advantage of having similar products competing is likely to be greater affordability for consumers.