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.
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.
This Week's Must Reads
Pediatric Onset MS Linked with Reduced Parental QOL, Mult Scler; ePub 2018 Aug 30; O’Mahony, et al
Depressive Symptoms Negatively Impact on MS, J Neuropsychiatry Clin Neurosci; ePub 2018 Sep 6; Gill, et al
Evaluation of the MULES Picture Naming Test, J Neurol Sci; ePub 2018 Aug 23; Seay, Akhand, et al
Postrelapse Rehabilitation Use in MS Examined , Int J MS Care; ePub 2018 Sep 5; Asano, Eitzen, et al
Thalamic White Matter in Patients with MS, Hum Brain Mapp; 2018 Oct; Bergsland, et al
Must Reads in FDA Actions
FDA Approves Diacomit for Treatment of Seizures, Biocodex news release; 2018 Aug 23
FDA Approves Drug for Rare Peripheral Nerve Disease, FDA Web site; 2018 Aug 10
FDA Approves Xeomin for Excessive Drooling, Merz North America news release; 2018 Jul 3
FDA Approves Epidiolex for Rare Epilepsy Forms, FDA news release: 2018 Jun 25
FDA Approves Medtronic’s DBS Therapy for Epilepsy, Medtronic news release; 2018 May 1