New Botulinum Toxin Receives FDA Approval for Treatment of Neurological Movement Disorders
Tuesday, August 3rd, 2010
XEOMIN is the latest botulinum toxin type A product to be approved by the FDA, after Botox and Dysport. A product of Merz Pharmaceuticals, XEOMIN has been approved for therapeutic treatment of adults with cervical dystonia or blepharospasm.
The National Institute of Neurological Disorders and Stroke defines dystonias as movement disorders in which sustained muscle contractions cause twisting and repetitive movements or abnormal postures. Focal dystonia, which includes cervical dystonia (twisting of the neck and sometimes the shoulders) and blepharospasm (excessive eyelid spasm), affects about 295 people out of one million in the U.S., according to a study conducted in Rochester, Minnesota.
The approval of XEOMIN comes after two U.S. clinical trials. The Journal of Neurological Sciences cited a study on the efficacy and safety of XEOMIN, in which XEOMIN showed “non-inferiority” to Botox when used to treat cervical dystonia. XEOMIN “is a safe and effective treatment for CD [cervical dystonia]” it concluded.
Xeomin, according to Merz, is the only botulinum toxin that doesn’t require refrigeration prior to reconstitution. Merz believes this may simplify product distribution and storage and help ensure product integrity at the time of injection.
Merz had announced earlier this year that it was acquiring BioForm Medical, a leader in the U.S. and European dermal filler markets with its Radiesse dermal filler. Merz will be renamed “Merz Aesthetics” after the acquisiton is complete.
