A single injection of Dysport (abobotulinumtoxinA) is safe and effective in treating lower limb spasticity due to cerebral palsy in children across different age groups, according to a pooled analysis from four clinical trials.
Ipsen Biopharmaceuticals presented these results during the 2018 Annual Meeting of the American Academy of Neurology (AAN), which took place recently in Los Angeles, along with further evidence demonstrating the clinical benefits of Dysport for the treatment of spasticity in other conditions.
Dysport is a form of botulinum toxin Type A, a compound produced from a bacterium that inhibits the transmission of nerve impulses to the muscle. Botulinum toxin injections cause contracted muscles to relax, enabling patients to return to many of their daily activities while relieving symptoms and improving their quality of life.
The U.S. Food and Drug Administration recently approved Ipsen Biopharmaceuticals’ supplemental Biologics License Application for Dysport injection for the treatment of lower limb spasticity in pediatric patients ages 2 and older.
“The analyses presented at AAN reinforce the efficacy and safety profile for Dysport in multiple therapeutic uses, doses and injection cycles,” Francois LaFleur, Ipsen’s vice president of global medical affairs in North and South America, said in a press release. “The results provide important confirmatory information for physicians when determining the appropriate treatment option for their adult and pediatric patients.”
The scientific poster, “Safety profile of abobotulinumtoxinA (Dysport®) for lower limb spasticity: Pooled analysis of controlled clinical trials,” revealed the safety profile of Dysport in 386 children with cerebral palsy and lower limb spasticity, between 2 and 17 years old, who had been treated with Dysport or placebo.
The incidence of adverse events due to Dysport treatment was similar across different age groups. Patients treated with the therapy had slightly more adverse events than the placebo-treated group. However, only one serious event was reported, consisting of moderate muscle pain and weakness in a child in the middle/high school age group who was the only patient to withdraw from the study.
“As the only FDA-approved treatment for lower limb spasticity in pediatric patients two years of age and older, these data reinforce the importance of having FDA-recommended dose ranges where the safety and tolerability of Dysport has been characterized,” LaFleur said. “A key point about this pooled analysis is the assessment of a large group of pediatric patients aged two to five, a sensitive age range when deciding upon a course of treatment.”
Two other studies, both presented as scientific posters at the AAN meeting, showed that multiple administrations of Dysport could improve patients’ spasticity due to stroke or traumatic brain injury, and that a single cycle of Dysport therapy in adult cervical dystonia patients — a condition characterized by involuntary contraction of neck muscles — was seen to ease symptoms “irrespective of treatment interval,” and further study was warranted.