FDA approves Myobloc for sialorrhea

US World Meds, LLC announced that the FDA approved the supplemental Biologics License Application (sBLA) for Myobloc (rimabotulinumtoxinB) injection for the treatment of chronic sialorrhea in adults. Myobloc, the first and only approved botulinum toxin type B, significantly decreases sialorrhea symptoms with a single treatment in as early as 1 week and lasts up to 3 months.

The sBLA approval is supported by multiple clinical trials, including a multicenter, double-blind, placebo-controlled, efficacy and safety study of Myobloc. The co-primary efficacy endpoints, measured by decreases in salivary production and improvements in symptoms from baseline, were successfully achieved and statistically significant versus placebo. An open-label portion of this study demonstrated Myobloc's safety and efficacy over time at subsequent dosing sessions for over 1 year. The most common adverse reactions reported in all studies for chronic sialorrhea were dry mouth, dental caries, and dysphagia.

Comment: Myobloc is currently available in three vial sizes to be prescribed and administered by a licensed healthcare provider and is the only botulinum toxin therapy available that requires no reconstitution. Myobloc was first approved by the FDA in 2000 for the treatment of adults with cervical dystonia.

Comment: Sialorrhea, or drooling, is defined as an excess spillage of saliva out of the mouth. Sialorrhea is a common and often problematic symptom of many neurological disorders, such as Parkinson's disease, amyotrophic lateral sclerosis, cerebral palsy, stroke, and other conditions. It affects up to 75% of people with PD and is considered one of the most bothersome non-motor symptoms of the disease.