26th June 2012 - News release

LCIG CLINICAL TRIAL RESULTS FOR PARKINSON'S DISEASE

Levodopa-carbidopa is administered in gel form, directly into the small intestine via a procedurally-implanted tube connected to a portable pump that delivers continuous supply of LCIG during waking hours. LCIG is currently approved in 40 countries. In the U.S.A., LCIG is an investigational therapy that is currently being evaluated in patients with advanced Parkinson's disease in additional Phase 3 clinical trials. Abbott have announced results from five abstracts evaluating levodopa-carbidopa intestinal gel (LCIG), concerning a 54 week open-label safety and tolerability study of people with advanced Parkinson's disease. The efficacy of LCIG was compared to that of standard levodopa-carbidopa immediate release, which is the same as Sinemet. There was nearly 2 hours less off time with LCIG.

The most common adverse events were complication of device insertion (33%), abdominal pain (30%), procedural pain (21%) and nausea (16%). The most common serious adverse events were complication of device insertion (6%), abdominal pain (3%) peritonitis (3%) and polyneuropathy (3%). 7% of patients withdrew due to at least one adverse event. In another clinical trial the most common adverse events were complication of device insertion (51%), abdominal pain (42%), procedural pain (32%), nausea (25%), constipation (21%), orthostatic hypotension (18%), post-operative wound infection (17%), and incision site erythema (16%).

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