Merz’s Xeomin gains FDA approval as first neurotoxin treatment for sialorrhea

FirstWord 2018/07/04

Merz announced that the FDA approved Xeomin (incobotulinumtoxinA) for the treatment of chronic sialorrhea in adults, making the product the first neurotoxin authorised in this indication in the US. Kevin O’Brien, US head of neurosciences at Merz, said “until now, there has not been an FDA approved treatment for this debilitating condition,” which is a common symptom among patients who suffer from neurological disorders including Parkinson’s disease, amyotrophic lateral sclerosis, cerebral palsy or who have experienced a stroke.

The FDA accepted the filing for Xeomin in sialorrhea in March, assigning the application priority review a target action date in the fourth quarter. The submission was based on data from a Phase III study in 184 patients with sialorrhea, which met both its co-primary endpoints. Results showed a significant improvement in change in unstimulated salivary flow rate and Global Impression of Change Scale, both at week four as compared to baseline pre-injection for subjects administered Xeomin versus placebo.

Merz noted that this is the fourth neurological indication for Xeomin, following previous FDA approvals for the treatment of cervical dystonia, blepharospasm and upper limb spasticity.