Botulinum Cleared by FDA for Cervical Dystonia

Botulinum toxin type A (Botox) has been cleared by the U.S. Food and Drug Administration (FDA) for the treatment of adults with cervical dystonia, a neurologic movement disorder characterized by involuntary muscle contractions that force the head and neck into abnormal and sometimes painful positions.

When injected into affected muscles, botulinum decreases the severity of abnormal head position and neck pain by blocking the release of the neurotransmitter acetylcholine from the peripheral nerve terminal to the muscle. The FDA approval was based on a phase III trial of 170 subjects designed to evaluate safety and efficacy. The subjects who took botulinum showed significantly greater improvements than placebo subjects in dereasing the severity of abnormal head position and neck pain.

Botox is the product of Allergan, Inc. (Irvine, CA, USA). "We will continue our aggressive investment in research and development to broaden our understanding of neurotoxin science and to register new clinical indications for Botox,” said Lester J. Kaplan, Ph.D., president, research and development and global Botox for Allergan.



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