Sanofi-aventis’s phase III results showed success in reducing relapses in multiple sclerosis (MS) leaving hope for another oral disease modifying therapy for those with the disease. There were two different doses (7 and 14mg) used along with the placebo and both were well tolerated for the most part and both reduced yearly relapse rates.
The drug was able to reduce disease activity in significant amounts according the MRI’s taken of each patient’s brain as well and long term safety showed surprising results in that the study allowed for eight years of continuous use. Surprising because Gilenya and Cladribine are oral drugs already on the market that are not to be taken longer than two years due to adverse affects and their being cytoxic which affects white blood cells.
This study was 2-years, double-blinded and placebo-controlled that had over a thousand patients ranging from ages 18 to 55 who received once daily either the placebo or the drug.
Marc Cluzel, M.D., Ph.D. and Executive Vice President of Research and Development of Sanofi-aventis has this to say, “We are very pleased with the successful results of the TEMSO study which are an important step forward in multiple sclerosis clinical research. These exciting results with teriflunomide represent a new real hope to delivering an oral therapy to patients who live with this serious condition and are eager for new treatment options, and more convenient product forms in-line with our sanofi-aventis commitment to multiple sclerosis.”
The safety issues weren’t such that led to anyone opting out of or being forced out of the study but they did include diarrhea, nausea and mild hair thinning and hair loss. These problems lead one to believe it is also cytoxic like the others and it just might prompt doctors and neurologists to go the way of the previous oral therapies in that they won’t feel safe allowing use after two years without a ‘break’.
“MS is so unpredictable and sometimes taking care of some of us can be so complex, that I am just so glad they are working on more and more of these therapies for us. The more that is out there for us to choose from the longer it will be, if ever, we will get stuck in wheelchairs or in beds,” says Pamela Vaughn of Lima.
For more info: for those who live in Lima, Ohio, the Northwestern Ohio MS Chapter can be reached at: 401 Tomahawk Drive, Maumee, OH at (419) 897-7263. They are located approximately an hour and a half from Lima, Ohio and 45 minutes from Findlay, Ohio. For directions please click here at Bing Maps.
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