Abbott Laboratories (ABT) said Tuesday a late stage trial of its investigational compound levodopa-carbidopa intestinal gel showed positive results in patients afflicted with advanced Parkinson's disease.
Results showed patients treated with levodopa-carbidopa intestinal gel, or LCIG, reported meaningful improvement in vital parameters such as mobility and stiffness without a concomitant increase in troublesome dyskinesia, compared to levodopa-carbidopa immediate release tablets.
Dyskinesias refer to involuntary movements associated with treatments used to manage Parkinson's disease.
Abbott's LCIG contains the same active medication as levodopa-carbidopa IR tablets but in gel form and is administered directly into the small intestine via a procedurally-implanted tube connected to a portable pump. LCIG is currently being evaluated in patients with advanced Parkinson's disease in additional Phase 3 clinical trials in the U.S. It is approved in 40 countries outside the U.S.
Abbott said the late stage study assessed the efficacy and safety of continuous LCIG infusion in patients with advanced Parkinson's disease compared to standard levodopa-carbidopa IR tablets.
At baseline, patients enrolled in the study had Parkinson's disease for an average of 10.9 years and experienced an average of 6.6 hours of "off" time a day - Off" time refers to the periods of poor mobility, slowness and stiffness experienced by patients.
The primary efficacy endpoint of the trial was change from baseline in daily "off" time (16 waking hours) at 12 weeks. Results showed that Mean "off" time at 12 weeks decreased by 4 hours per day with LCIG, an average of 1.91 fewer hours of "off" time compared to levodopa-carbidopa IR tablets.
Adverse events were similar and occurred in 95 percent of patients on LCIG, while it was 100 percent for those on levodopa-carbidopa IR tablets. Most of these events pertained to complication of device insertion, abdominal pain, nausea, constipation, orthostatic hypotension, among others.
Serious adverse events were reported in 14 percent of patients in the LCIG arm, while it was 21 percent in the levodopa-carbidopa IR tablets arm. All patients that experienced an SAE recovered.
"These results demonstrate that continuous delivery of levodopa-carbidopa intestinal gel produces statistically meaningful improvements in advanced PD patients by decreasing 'off' time and increasing 'on' time without troublesome dyskinetic symptoms," said C.W. Olanow, Professor of Neurology and Neuroscience at the Mount Sinai School of Medicine in New York City.
"These benefits in a patient group that cannot be satisfactorily controlled with standard levodopa, represent an important step forward in our efforts to treat advanced PD patients," Olanow added.
Parkinson's disease is a movement disorder resulting from progressive loss of brain cells that produce the chemical dopamine, which helps to control movement of the body. The disease is characterized by tremor, muscle rigidity, slowness of movement and difficulty with balance.
Patients in early stage of the disease respond well to medications that raise dopamine levels, but as the condition worsens, oral medications apart from being less effective can also aggravate side effects.
It is estimated that in the U.S. alone about 50,000 to 60,000 new cases of Parkinson's disease are reported each year. About 20 percent of these patients are considered have an advanced condition.
The LCIG study spanned 12 weeks and was a double-blind, double-dummy trial (meaning all patients were given both placebo and active doses of either oral medication or LCIG during the study).
ABT closed Tuesday at $60.43, up $0.58 or 0.97%, on a volume of about 6 million shares on the NYSE. In after hours, the stock gained 0.45%.
by RTT Staff Writer
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