Merz’s Xeomin meets in Phase III trial for PD-associated sialorrhea

The Merz Neurosciences unit of Merz GmbH & Co. KGaA (Frankfurt, Germany) reported top-line data from the Phase III SIAXI trial to treat sialorrhea associated with Parkinson’s disease (PD) and other neurological disorders showing that Xeomin incobotulinumtoxinA (Bocouture, Xeomin Cosmetic, NT 201) met the co-primary endpoints of improving unstimulated salivary flow rate (uSFR) and patients’ Global Impression of Change Scale (GICS) score from baseline at week 4 vs. placebo (p=0.004 and p=0.002, respectively).

The double-blind, Polish and German trial enrolled 184 patients with sialorrhea, or unwanted drooling, to receive placebo or single treatment of 75 or 100 U Xeomin delivered via 4 injections into bilateral parotid and bilateral submandibular salivary glands. Secondary endpoints include the change from baseline in uSFR and GICS score at week 12. Data were presented at the International Congress of Parkinson’s Disease and Movement Disorders in Vancouver...