Washington — The Food and Drug Administration (FDA) has approved Xeomin (incobotulinumtoxinA, Merz Aesthetics) for temporary improvement of moderate to severe glabellar lines, Medscape Today reports.
According to a Merz statement, the approval is based on the results of two multicenter U.S. clinical trials involving 547 healthy adults. In both studies, Xeomin injections significantly improved the appearance of glabellar lines in 30 days when compared with placebo. Headache was the most common adverse reaction observed.
Under the brand name Bocouture, Xeomin is already approved in 14 European countries including Germany, the United Kingdom, France, Italy and Spain. It was FDA-approved in 2010 for the treatment of cervical dystonia and blepharospasm.
Xeomin will be available nationwide in the spring of 2012, Merz officials said.