FDA Approves Myobloc (rimabotulinumtoxinB) Injection for Chronic Sialorrhea

By | August 27, 2019

LOUISVILLE, Ky., Aug. 26, 2019 /PRNewswire/ — US WorldMeds, LLC announced today that the U.S. Food and Drug Administration (FDA) approved the supplemental Biologics License Application (sBLA) for Myobloc (rimabotulinumtoxinB) injection for the treatment of chronic sialorrhea in adults.1 

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 (PD), amyotrophic lateral sclerosis (ALS), cerebral palsy, stroke, and other conditions.3,4 It affects up to 75% of people with PD and is considered one of the most bothersome non-motor symptoms of the disease.5,6

Stuart Isaacson, MD, Director of the Parkinson’s Disease and Movement Disorder Center of Boca Raton, explains, “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. In some cases, pooling of saliva can lead to choking and aspiration pneumonia. In addition to the physical consequences, the social stigma associated with drooling can be severe enough to result in social withdrawal.  These impacts can leave patients with compromised physical wellbeing, as well as feeling embarrassed by their condition, causing a lack of confidence and isolation.” 3,5-8

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.1,2

“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,” said P. Breckinridge Jones, CEO of US WorldMeds. “We are proud to support health care providers with an option that can have such a positive impact on the lives of patients and their caregivers.”

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.

About Myobloc (rimabotulinumtoxinB) injection

Myobloc is a prescription medicine that is: 
– injected into neck muscles and used to treat the abnormal head position and neck pain that happens with cervical dystonia in adults. 
– injected into the salivary glands (parotid and submandibular glands) and used to treat chronic sialorrhea in adults.

About US WorldMeds 

US WorldMeds is a specialty pharmaceutical company whose products are making a difference in the lives of the patients and communities it serves. US WorldMeds takes an agile and personal approach to pharmaceuticals – pioneering research and product development in therapeutic areas that desperately need new solutions. Headquartered in Louisville, Kentucky, US WorldMeds has global presence and nearly 20 years of experience in the development, licensure, and commercialization of unique products. For more information about US WorldMeds, visit http://www.usworldmeds.com/. Follow US WorldMeds on Twitter, LinkedIn, and on Facebook.

References:

  1. Myobloc® US Prescribing Information. Solstice Neurosciences, LLC; Louisville, KY:2019.
  2. Chinnapongse R, Gullo K, Nemeth P, Zhang Y, Griggs L. Safety and efficacy of botulinum toxin type B for treatment of sialorrhea in Parkinson’s disease: a prospective double-blind trial. Mov Disord. 2012;27(2):219-226.
  3. Leibner J, Ramjit A, Sedig L, Day Y, Wu SS, Jacobsen C, et al. The impact of and the factors associated with drooling in Parkinson’s diseases. Parkinsonism Relat Disord. 2010;16(7):475-477.
  4. Jackson, CE et al. Randomized double-blind study of botulinum toxin type B for sialorrhea in ALS patients. Muscle Nerve. 2009;39(2):137-143.
  5. Hockstein NG, et al. Sialorrhea: a management challenge. Am Fam Physician. 2004;69(11):2628-2634.
  6. Martinez-Martin P, et al. The impact of non-motor symptoms on health-related quality of life of patients with Parkinson’s disease. Movement Disord. 2011;26(3):399–406.
  7. Ozdilek B, Gunal DI. Motor and non-motor symptoms in Turkish patients with Parkinson’s disease affecting family caregiver burden and quality of life. J Neuropsychiatry Clin Neurosci. 2012;24:478-483.
  8. Benson J, Daugherty KK. Botulinum toxin A in the treatment of sialorrhea. Ann Pharmacother. 2007;41:79-85.
    USWMMYO-00021  08/19

Myobloc is a registered trademark of Solstice Neurosciences, LLC, a wholly-owned subsidiary of US WorldMeds, LLC.

SOURCE US WorldMeds, LLC

Posted: August 2019

Drugs.com – New Drug Approvals