US WorldMeds LLC announces that the US Food and Drug Administration (FDA) has approved its supplemental Biologics License Application (sBLA) for MYOBLOC (rimabotulinumtoxinB) injection for the treatment of chronic sialorrhea in adults.
Sialorrhea, or drooling — defined as an excess spillage of saliva out of the mouth — is a common symptom of Parkinson’s disease (PD), amyotrophic lateral sclerosis (ALS), 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, according the company in a media release.
“Sialorrhea can be highly distressing for patients and their caregivers and can have a significant, negative impact on quality of life. If left untreated, pooling of saliva can lead to irritation of the skin around the mouth, oral hygiene complications, speech difficulties, and sleep interruption,” says Stuart Isaacson, MD, director of the Parkinson’s Disease and Movement Disorder Center of Boca Raton, in the release.
“In some cases, pooling of saliva can lead to choking and aspiration pneumonia,” he adds. “In addition to the physical consequences, the social stigma associated with drooling can be severe enough to result in social withdrawal.”
MYOBLOC, reportedly 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, the release explains.
“We are committed to helping patients who struggle with confidence due to their sialorrhea. This new indication for MYOBLOC offers a fast-acting and proven treatment,” states P. Breckinridge Jones, CEO of US WorldMeds.
MYOBLOC is currently available in three vial sizes to be prescribed and administered by a licensed healthcare provider and is reportedly the only botulinum toxin therapy available that requires no reconstitution, per the release.
MYOBLOC was first approved by the FDA in 2000 for the treatment of adults with cervical dystonia.
[Source(s): US WorldMeds LLC, PR Newswire]