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Early News About Experimental Gel Form of Parkinsonís Medication
- Jun 15 2011
Abbott Laboratories has issued an announcement about the interim results of its on-going Phase III 54-week open-label, multi-site study, which tested the use of levodopa-carbidopa intestinal gel for treatment of advanced Parkinson's disease. This investigational therapy – which is pumped directly during daytime hours into the small intestine via a portable pump connected to a surgically-implanted gastric tube – is still being studied.
The interim efficacy and safety results, covering the first 12 weeks of study, were reported last week at the Movement Disorder Society 15th International Congress of Parkinson's Disease and Movement Disorders.
According to the company press release, the medication’s design is intended to lessen the spikes associated with oral formulations of the medication; spikes which can be associated with an increase in dyskinesias. The company also reports that adverse events occurred in 87.5 percent of participants and appeared to be largely related to the surgical procedure. Additionally, the company notes that the medication is currently approved for use in 38 other countries.
PDF notes that the data has not yet been published in a peer-reviewed journal, so we cannot yet comment on the data itself. Our Medical Policy Committee is monitoring the situation and will report when more information is available.
Please see the statement below for more information on this development.
Abbott's Parkinson's Treatment Shows Promise in Early Tests
(AP) — Drug developer Abbott Laboratories said Thursday preliminary results from a late-stage study of a potential Parkinson's disease treatment showed that it helped provide longer periods of relief from symptoms of the disease.
The North Chicago, Ill., company also said its levodopa-carbidopa intestinal gel also increased the time in which dyskinesias was well-managed. Dyskinesias involves involuntary movements tied to most treatments used to manage the disease.
Abbott is conducting a 54-week study of patients and released results to show what happened after 12 weeks. The company will receive results from another late-stage study around the end of the year and then determine the timing of a possible submission to the Food and Drug Administration for regulatory approval, a spokeswoman said.
The gel is infused directly into the small intestine during daytime hours through a portable pump connected to a surgically-implanted tube. It is already approved for use in 38 countries.
Parkinson's disease is a debilitating brain disorder that has no cure and causes tremors and movement problems.
Abbott shares climbed 46 cents to $51.99 in morning trading.
Source Date: Jun 09 2011
Source Publication: Crain's Chicago Business
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