US Food and Drug Administration approves paediatric indication for Xeomin® (botulinum toxin A) for treatment of chronic sialorrhea

Approval based on Phase 3 RCT (n= 255); Xeomin significantly reduced unstimulated Salivary Flow Rate and Global Impression of Change Scale score at week 4 vs. placebo and sustained efficacy over 64 weeks. Currently in UK, Xeomin is only licensed for chronic sialorrhea in adults

Source:

Biospace Inc.