FDA approves Merz's Xeomin

GREENSBORO, N.C. The Food and Drug Administration has approved a treatment for muscle spasms and twitches.

Merz Pharmaceuticals announced Monday the approval of Xeomin (incobotulinumtoxinA), a treatment for cervical dystonia and blepharospasm. Cervical dystonia and blepharospasm belong to a class of disorders known as focal dystonias, which cause sustained muscle contractions resulting in twisting and repetitive movements, affecting the neck and eyelids, respectively. Focal dystonias affect around 295-out-of-every-1-million Americans, according to an epidemiology study conducted in Rochester, Minn.

“This is an important regulatory milestone for Xeomin and is key to establishing our neurology business in the U.S.,” Merz Pharmaceuticals president and CEO Jack Britts said. “We at Merz understand and are committed to addressing the complexities of treating and living with these neurological disorders.”

The drug is derived from botulinum toxin, the same basic ingredient of Allergan’s wrinkle treatment Botox (onabotulinumtoxinA), which is also used to treat focal dystonias.