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MYSTICOL: MYobloc for Sialorrhea Treatment with Intraglandular injections - Controlled and Open-Label

US WorldMeds has launched a Phase III clinical trial studying the use of MYOBLOC® (rimabotulinumtoxinB) Injection for the treatment of sialorrhea in adults, with a goal of obtaining FDA approval for this indication. Commonly known as "drooling," sialorrhea frequently occurs in patients who may have difficulty swallowing due to neurological disorders such as Parkinson's disease, Lou Gehrig's disease, stroke, brain injury and cerebral palsy. Drooling can also be caused by oral cancers or as a side effect to certain medications, such as drugs used to treat Schizophrenia.

MYOBLOC is currently FDA-approved and indicated for the treatment of adults with cervical dystonia to reduce the severity of abnormal head position and neck pain associated with cervical dystonia.

MYOBLOC has also been studied in several prior clinical trials in the United States as reported in published manuscripts, including an earlier Phase II study of 54 Parkinson's disease patients with sialorrhea.

This MYOBLOC trial is a nationwide, multicenter, double-blinded, placebo-controlled study that will enroll patients who have been diagnosed with sialorrhea due to multiple causes. MYOBLOC will be injected directly into the salivary glands, and the efficacy and safety will be analyzed over the course of 1 year. When MYOBLOC is injected directly into the salivary glands, it inhibits the release of the neurotransmitter acetylcholine, resulting in decreased saliva production, thereby decreasing drooling.

Currently, investigators are recruiting individuals with troublesome sialorrhea at the following sites throughout the United States: Albany, NY; Aurora, CO; Baltimore, MD; Boca Raton, FL; Carmel, IN; Cincinnati, OH; Edison, NJ; Escondido, CA; Houston, TX; Kirkland, WA; Los Angeles, CA; Memphis, TN; New York, NY; Port Charlotte, FL; Port Royal, SC; Salt Lake City, UT; San Antonio, TX; Southfield, MI; St. Louis, MO; Tacoma, WA; Tulsa, OK; Washington, DC; and West Bloomfield, MI.

For more information on the Phase III MYOBLOC trial, contact clinicaltrials@usworldmeds.com or click here.