The Food and Drug Administration (FDA) has approved Botox (onabotulinumtoxinA; Allergan) for the treatment of upper limb spasticity in pediatric patients 2-17 years of age.
The approval was based on data from two phase 3 trials: a 12-week study that evaluated the efficacy and safety of Botox in 234 pediatric patients with upper limb spasticity (modified Ashworth Scale [MAS] elbow or wrist score of at least 2) because of cerebral palsy or stroke, and a 1-year open label extension study (N=222) evaluating the treatment over a 60 week period.
In the 12-week trial, the co-primary endpoints were the average of the change from baseline in MAS principal muscle group score (elbow or wrist), and the average of the Clinical Global Impression of Overall Change by Physician (CGI; a 9-point scale where: -4=very marked worsening to +4=very marked improvement), both at week 4 and 6.
Findings from the study showed that treatment with Botox resulted in significant improvements in MAS change from baseline at all timepoints, compared with placebo (Week 4 and 6 average: Botox 3 Units/kg: -1.92; Botox 6 Units/kg: -1.87; placebo: -1.21; P <.05). Although not statistically significant, CGI scores numerically favored Botox over placebo (Week 4 and 6 average: Botox 3 Units/kg: 1.88; Botox 6 Units/kg: 1.87; placebo: 1.66). The most frequently reported adverse reaction following Botox injection in pediatric patients with upper limb spasticity was upper respiratory tract infection.
“This FDA approval is special to all of us at Allergan because we can now provide children and their caregivers an advancement in pediatric care with Botox,” said David Nicholson, Chief Research and Development Officer, Allergan. “We also look forward to the FDA’s decision on pediatric lower limb spasticity and continuing to serve our patients globally.”
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