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FDA Approves IncobotulinumtoxinA for the Treatment of Cervical Dystonia and Blepharospasm
"This is an important regulatory milestone for XEOMIN and is key to establishing our neurology business in the U.S.," said Jack Britts, President and CEO of Merz Pharmaceuticals, LLC. "We at Merz understand, and are committed to, addressing the complexities of treating and living with these neurological disorders."
The FDA approval of XEOMIN is based on the results of two pivotal U.S. clinical trials involving adult patients diagnosed with either cervical dystonia or blepharospasm. Additionally, active comparator studies conducted in Europe evaluating XEOMIN versus Botox® (onabotulinumtoxinA) were included among the data submitted in support of the registration filing in these conditions.
XEOMIN is the only botulinum toxin that does not require refrigeration prior to reconstitution. Merz believes this may simplify product distribution and storage, and help ensure product integrity at the time of injection. XEOMIN will be available in 50-unit and 100-unit vials allowing dosing flexibility for administration.
Dystonias are neurological movement disorders in which sustained muscle contractions cause twisting and repetitive movements or abnormal postures. These movements, which are involuntary and sometimes painful, may affect a single muscle (focal), a group of muscles such as those in the arms, legs, or neck (segmental), or even the entire body (generalized). Symptoms can be mild or severe and dystonias may be markedly disabling.
Although dystonia is thought to be rare, it is possibly undiagnosed or misdiagnosed due to lack of specific clinical criteria. While focal dystonia, such as blepharospasm or cervical dystonia, can affect people at any age, most people first experience symptoms in middle age.
According to an epidemiology study conducted in Rochester, Minnesota, 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 295 per million people in the U.S. Dystonias can be disabling, painful and often interfere with patients' daily activities.
Source: Merz Pharmaceuticals