The US Food and Drug Administration (FDA) has approved abobotulinumtoxinA (Dysport, Ipsen Biopharmaceuticals Inc) injection for treatment of lower-limb spasticity in children as young 2 years.
Dysport is the first and only FDA-approved botulinum toxin for the treatment of pediatric lower-limb spasticity, the company said in a news release.
Dysport was tested in a phase 3 multicenter, double-blind, randomized, placebo-controlled study in 235 children aged 2 to 17 years with lower-limb spasticity due to cerebral palsy causing equinus foot deformity. Patients were randomly allocated to Dysport or placebo injected into the gastrocnemius-soleus muscle complex.
Dysport provided statistically significant improvement in co-primary efficacy assessments: mean change from baseline in Modified Ashworth Scale in ankle plantar flexor muscle tone and mean Physician Global Assessment response to treatment score at week 4 and 12, the company said.
Most patients in the clinical study were eligible for retreatment between 16 and 22 weeks; however, some had a longer duration of response.
"The degree and pattern of muscle spasticity and overall clinical benefit at the time of re-injection may necessitate alterations in the dose of Dysport and muscles to be injected," the company said.
The most common adverse reactions with Dysport were nasopharyngitis, upper respiratory tract infections, influenza and pharyngitis, cough, and pyrexia.
Results of the phase 3 study were published earlier this year in Pediatrics.
"AbobotulinumtoxinA improves muscle tone in children with dynamic equinus resulting in an improved overall clinical impression and is well tolerated," the study team concluded in their article.
"The approval of abobotulinumtoxinA means that, for the first time in the USA, physicians have an FDA-approved botulinum toxin and recommended dosing and administration guidance for the treatment of children from 2 years of age and older with lower limb spasticity," Mauricio R. Delgado, MD, from the University of Texas Southwestern Medical Center in Dallas, and the US principal investigator of the trial, said in the news release.
Dysport is currently approved in the United States for treatment of adults with cervical dystonia and adults with upper-limb spasticity to decrease the severity of increased muscle tone in elbow flexors, wrist flexors, and finger flexors.
Dysport and all botulinum toxin products include a boxed warning stating that the effects of the botulinum toxin may spread from the area of injection to other areas of the body, causing symptoms similar to those of botulism. Those symptoms include swallowing and breathing difficulties that can be life-threatening.
Full prescribing information for Dysport is available here.
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Cite this: FDA Clears Dysport for Lower-Limb Spasticity in Kids - Medscape - Aug 03, 2016.