Xeomin (incobotulinumtoxinA), made by Merz Pharmaceuticals, is approved by the US FDA for the treatment of adults with cervical dystonia or blepharospasm and Moderate to severe frown lines between the eyebrows. IncobotulinumtoxinA is made from the bacteria that causes botulism. Botulinum toxin blocks nerve activity in the muscles, causing a temporary reduction in muscle activity.
FDA approval of XEOMIN, was based on the results of two U.S. clinical trials. A study cited in the Journal of Neurological Sciences on the efficacy and safety of XEOMIN found it showed “non-inferiority” to Botox when used in the same doses to treat cervical dystonia. It concluded that XEOMIN is a safe and effective treatment for the disorder.
Xeomin has now been approved for some cosmetic indications – Moderate to severe frown lines between the eyebrows. Similiar to other drugs in this category, including Botox and Dysport, that also have FDA approval for the treatment of facial wrinkles. Now that Xeomin is available and FDA approved, doctors can use it both on-label and off-label to treat the same facial lines treated by Botox and Dysport, including frown lines, crow’s feet and forehead wrinkles.
Worldwide, more than 84,000 people have been treated with Xeomin injections. The U.S. is actually the 20th country to approve this new drug. It is available in 50-unit and 100-unit vials.