US WorldMeds, LLC, has launched a final phase III clinical trial to investigate the use of Myobloc (rimabotulinumtoxinB) injection to obtain US FDA approval of an indication for sialorrhea, commonly known as “drooling.” This “drooling” is common 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. This disorder can be socially debilitating, but evidence suggests that the swallowing difficulty and untreated ‘drooling’ may potentially contribute to other more serious medical complications, such as skin breakdown and respiratory infections. Currently, there is no approved pharmacological treatment for ‘drooling’ in adults.

“As a neurologist, I see the consequences that sialorrhea has on my patients’ quality of life," stated Fernando Pagan MD, associate professor of Neurology, and director of the Movement Disorders Programme at Georgetown University Hospital in Washington, DC. "I’m thrilled with the possibility of gaining an indication for this condition through this Myobloc trial, and I’ve already seen my patients benefit from treatment with Myobloc." Dr Pagan continued, "This potential new indication will make sialorrhea treatment uniformly available to patients in the United States in need of relief.”

This Myobloc trial is a nationwide, multicentre, 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 one 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.

Myobloc is the only type B botulinum toxin, and is a ready-to-use injectable medication currently indicated for the treatment of cervical dystonia in adults, a condition of abnormal contraction of the muscles of the head and neck, resulting in distorted head positioning and, very commonly, severe pain. Myobloc is injected directly into the dystonic muscles of the neck, which inhibits the release of acetylcholine. The result of these injections is decreased abnormal muscle contractions and pain, typically lasting three to four months.

Myobloc trial sites are located in Albany, New York; Aurora, Colorado; Baltimore, Maryland; Bedford, Texas; Boca Raton, Florida; Cleveland, Ohio; Escondido, California; Houston, Texas; Kirkland, Washington; Los Angeles, California; New York; Port Charlotte, Florida; Port Royal, SC; Salt Lake City, UT; San Antonio, Texas; Southfield, Michigan; St. Louis, MO; Tacoma, Washington; Tulsa, OK; and Washington, DC.

US WorldMeds is a closely-held, Kentucky-based specialty pharmaceutical company. Its mission is to develop, license and commercialize unique and significant specialty pharmaceuticals that address unmet medical needs or overcome limitations of existing products.