The U.S. Food and Drug Administration (FDA) has expanded the use Dysport (botulinum toxin type A) to include the treatment of upper limb spasticity in children two years of age and older, excluding spasticity caused by cerebral palsy. The FDA previously approved Dysport to treat children with lower limb spasticity aged two and older received in 2016.
In a press release, Ann Tilton, MD, study investigator and Professor of Clinical Neurology at the Louisiana State University Health Sciences Center New Orleans said, “For physicians, it is reassuring to have a botulinum toxin treatment in Dysport which demonstrated sustained symptom relief for spasticity, which can be physically challenging for children. ” Dr. Tilton added, “This FDA decision for Dysport means we now have an approved therapy to offer children and adolescents seeking improvements in mobility in both upper and lower limbs.”
The approval is based on a Phase III randomized, double-blind, low-dose controlled, multicenter study involving 210 children, aged two to 17 years, treated for upper limb spasticity. Children receiving Dysport demonstrated statistically significant improvements from baseline at Week 6 with doses of 8 Units/kg and 16 Units/kg vs. 2 Units/kg, as measured by the Modified Ashworth Scale (MAS) in the elbow or wrist flexors. The most frequent adverse reactions observed were upper respiratory tract infection and pharyngitis.
Dysport, like all botulinum toxin products, comes with a Boxed Warning stating that the effects of the botulinum toxin may spread from the injection area to other regions of the body, causing symptoms similar to those of botulism (difficulty swallowing and breathing that can be life-threatening).