UCB Inc, Atlanta, presented positive results from two Phase III pivotal trials of its restless leg syndrome (RLS) drug, Rotigotine, at the 132nd annual meeting of the American Neurological Association in Washington, DC.
Data showed that Rotigotine substantially reduced RLS symptoms, “including changes of up to 8 points over placebo using the International Restless Legs Syndrome Study Group Rating Scale (IRLS) and a reduction in disease severity over a two-year period.”
In the two six-month trials led by Wayne Hening, MD, assistant clinical professor of neurology at the Robert Wood Johnson Medical School, Rotigotine produced significant reductions in RLS symptoms compared to placebo. The drug was also generally well-tolerated.
Rotigotine Transdermal System is currently approved domestically and in Europe for early-stage idiopathic Parkinson’s disease. Applications for approval from the FDA and EMEA (Europe) to market Rotigotine as a treatment for moderate-to-severe RLS are currently being prepared.
To read the full release, click here.