The U.S. Food and Drug Administration has approved XEOMIN, a botulinum toxin type A for treating adults with cervical dystonia or blepharospasm. This is the third product of this kind to be approved in the U.S., after Botox and Dysport.
Dystonias are movement disorders in which sustained muscle contractions cause twisting and repetitive movements or abnormal postures, according to the National Institute of Neurological Disorders and Stroke. Focal dystonia, which includes cervical dystonia, and may be characterized by twisting of the neck, and blepharospasm, or excessive eyelid spasm, is estimated to affect about 295 out of one million people in the U.S., according to a study conducted in Rochester, Minnesota.
The FDA approval of XEOMIN, a product of Merz Pharmaceuticals, is based on the results of two U.S. clinical trials. In a study cited in the Journal of Neurological Sciences on the efficacy and safety of XEOMIN, it showed “non-inferiority” to Botox when used in the same doses to treat cervical dystonia. The study concluded that XEOMIN is a safe and effective treatment for the disorder.
XEOMIN is the only botulinum toxin that doesn’t require refrigeration prior to reconstitution, and Merz therefore believes this may “simplify product distribution and storage and help ensure product integrity at the time of injection.”
Earlier this year, Merz announced it would be acquiring BioForm Medical, a leader in the dermal filler market in the U.S. and Europe with its Radiesse dermal filler. Following completion of the acquisition, Merz and will be renamed “Merz Aesthetics.”
