Merz North America announced that the Food and Drug Administration (FDA) has approved Xeomin (incobotulinumtoxinA) for the treatment of chronic sialorrhea in adult patients, making it the first neurotoxin with this approved use in the US.
Sialorrhea is often seen in patients with various neurological disorders, including Parkinson’s disease, amyotrophic lateral sclerosis (ALS), cerebral palsy (CP) or in patients who have had a stroke. Xeomin is recommended for injection into the parotid and submandibular glands on both sides (ie, 4 injection sites per treatment session).
The approval was supported by data from a Phase 3, randomized, double-blind, placebo-controlled, multicenter (N=184) trial. Study patients who had chronic sialorrhea for ≥3 months were assigned to placebo, Xeomin 75 Units, or Xeomin 100 Units. The data showed a statistically significant improvement in change in unstimulated Salivary Flow Rate (uSFR) and Global Impression of Change Scale (GICS) at week 4 vs baseline pre-injection for patients in the Xeomin 100 Units group (P =.004 and P =.002, respectively); Xeomin 75 Units did not perform significantly better than placebo.
The overall incidence of adverse events was similar between placebo and treatment arms; no new or unexpected events were observed.
Xeomin, an acetylcholine release inhibitor and neuromuscular blocking agent, is already indicated to treat cervical dystonia, blepharospasm (in patients previously treated with onabotulinumtoxinA), and upper limb spasticity in adults. It is available as 50 Units, 100 Units, and 200 Units lyophilized powder in single-dose vials.
For more information call (888) 4-XEOMIN or visit Xeomin.com.