Clinical Edge

Summaries of Must-Read Clinical Literature, Guidelines, and FDA Actions

FDA Approves Xeomin for Excessive Drooling

Merz North America news release; 2018 Jul 3

Merz North America has announced that the US Food and Drug Administration (FDA) has approved the supplemental Biologics License Application (sBLA) for Xeomin (incobotulinumtoxinA) for the treatment of chronic sialorrhea, or excessive drooling, in adult patients. Xeomin is the first and only neurotoxin with this approved indication in the US. Merz North America is headquartered in Raleigh, NC.

Sialorrhea is a common symptom among patients who suffer from neurological disorders including Parkinson disease, amyotrophic lateral sclerosis (ALS), cerebral palsy (CP), or who have experienced a stroke. The condition can occur from difficulty retaining saliva inside the mouth, issues with swallowing and from problems controlling facial muscles.

Indications: Xeomin is an acetylcholine release inhibitor and neuromuscular blocking

agent indicated for the treatment or improvement of adult patients with chronic sialorrhea.

Dosage/administration: For chronic sialorrhea, the recommended total dose is 100 units per treatment session consisting of 30 units per parotid gland and 20 units per submandibular gland, no sooner than every 16 weeks.

Adverse reactions: The most commonly observed adverse reactions in patients with chronic sialorrhea, at rates specified below and greater than placebo, are tooth extraction, dry mouth,

diarrhea, and hypertension.

Citation:

FDA approves Xeomin (incobotulinumtoxinA) for adult patients with sialorrhea. [news release]. Raleigh, NC: Merz North America. July 3, 2018. https://www.businesswire.com/news/home/20180703005550/en/FDA-Approves-XEOMIN%C2%AE-incobotulinumtoxinA-Adult-Patients-Sialorrhea. Accessed July 10, 2018.