Analysis of Dysport demonstrates consistent safety profile in lower limb spasticity.- Ipsen Biopharma.

Ipsen Biopharmaceuticals has presented data on Dysport (abobotulinumtoxinA) in lower limb spasticity at the annual meeting of the American Academy of Neurology. A pooled analysis of safety data from four placebo-controlled clinical trials in 386 children aged two to 17 years old with lower limb spasticity due to cerebral palsy was conducted. Results showed that the safety profile of Dysport across age groups is consistent. Most adverse events (AEs) reported were related to common childhood illnesses.

The preschool group included 299 children aged two to five years (Dysport=195; placebo=104), the elementary school group included 134 children aged six to nine years (Dysport=87; placebo=47) and the middle/high school group included 43 children aged 10+ years (Dysport=30; placebo=13). Individual adverse event data for each study were pooled to form one database. Rates of treatment emergent adverse events (TEAEs) (Dysport vs. placebo) were: preschool (60.5 percent vs. 52.9 percent), elementary school (58.6 percent vs. 36.2 percent), middle/high school (40.0 percent vs. 46.2 percent). Rates of TEAEs considered related to Dysport treatment were low across all age groups: preschool (14.9 percent vs. 8.7 percent), elementary school (11.5 percent vs. 2.1 percent), middle/high school (6.7 percent vs. 15.4 percent). The only serious TEAE considered to be treatment related occurred in a middle/high school aged child (moderate muscle pain and weakness in the 30 U/kg group), which led to the only premature study withdrawal (Abstract #323).