Oral Drug Shows Promise To Multiple Sclerosis Sufferers
A new oral drug - fingolimod (FTY720) - effectively reduced relapse rates of multiple sclerosis patients in a clinical trial.
The trial was conducted by researchers at University Vita-Salute San Raffaele, Milan, Italy and funded by Novartis. The drug is expected to be filed for approval in 2009.
The trial of the Multiple Sclerosis drug involved 281 patients suffering from relapsing multiple sclerosis. They were given to 1.25mg or 5mg of fingolimod or a placebo during a 6 month period. After the first 6 month the trial was extended with 173 patients remained. These patients were switched to a 1.25mg dose because of safety measures.
The study concluded, that after 3 years of fingolimod treatment 73% of those who started the trial with a 5mg dose remained relapse free, 68% of those who started the trial with a 1.25mg dose remained relapse free, 51% of those taking a placebo also remained relapse free. These figures were 77%, 75% and 57% accordingly at the 2nd year of the study.
By the end of the study relapse rate was estimated to be about 0.20, which means that a relapse can occur once in 5 years for each patient. 89% of trial participants were shown to have no active brain lesions.
In other words, the 3 year trial showed relapse cut in more than 2/3 of multiple sclerosis patients during the study.
Fingolimod is aimed at fighting inflammation. The drug modulates sphingosine-1-phosphate receptors and reduces the number of lymphocytes reaching the brain. Lymphocytes are inflammatory immune cells that are causing multiple sclerosis when they reach the brain.
There are effective multiple sclerosis treatments available for patients, but all of them are injected subcutaneously or intramuscularly. Therefore, fingolimod (FTY720) will be a significant change for disease sufferers. This once-a-day pill will come to replace painful injections and improve quality of life.