Abbott reports interim phase 3 results of advanced Parkinson's treatment

In an interim analysis of the long term study, data were analyzed from 192 patients with advanced Parkinson's disease who had completed 12 weeks of treatment with LCIG for 16 hours per day. The primary efficacy endpoint is change from baseline to endpoint in "off" time at 54 weeks. At 12 weeks, patients reported an average of 3.9 fewer hours of "off" time and 4.6 additional hours of "on" time without troublesome dyskinesias. Adverse events occurred in 168 patients (87.5 percent) and appeared to be largely related to the surgical procedure.

The most common adverse events were abdominal pain (30.7 percent), complications of device insertion (21.4 percent) and procedural pain (17.7 percent). The most severe complications from surgery were peritonitis (abdominal inflammation, 3.6 percent) and pneumoperitoneum (gas or air in the peritoneal cavity, 5.7 percent). Fourteen patients (7.3 percent) withdrew due to an adverse event.

"With advanced Parkinson's disease, the goal of treatment is to provide patients with as much "on" time as possible, while limiting the troublesome dyskinesias they may experience," said Alberto Espay, MD, Assistant Professor of Neurology, University of Cincinnati Neuroscience Institute, Director of Clinical Research, Gardner Family Center for Parkinson's disease and one of the lead investigators. "The interim data from this study of LCIG show clinically meaningful improvements in these important measures."

LCIG is an investigational therapy that is being evaluated for the treatment of advanced-stage Parkinson's disease to achieve continuous dopaminergic stimulation for up to 16 hours. Oral forms of levodopa and carbidopa have been used in the treatment of Parkinson's disease for more than 40 years. As the disease progresses, patients may experience motor fluctuations that increase in severity and become difficult to treat. LCIG is administered via a surgically-implanted tube connected to a portable pump that delivers the medication directly to the small intestine, where it is then absorbed into the bloodstream, providing a continuous delivery of medication.

"Patients with advanced Parkinson's disease currently have few treatment options to help them manage the disease and it becomes progressively more debilitating," said Eugene Sun, MD, Vice President, Global Pharmaceutical Clinical Development, Abbott. "We look forward to additional data from ongoing studies and will continue our efforts to bring LCIG forward as a potential option for patients who no longer respond adequately to optimized oral treatment."

LCIG currently is in phase 3 development in the United States and is approved for use in 38 countries.