There were over 2,000 patients studied in clinical trials for FTY 720 multiple sclerosis, the first oral therapy for the relief of MS symptoms. Approval was sought by the drug company Novaris before the US Food and Drug Administration (FDA) and European Medicines Agency (EMEA) in December 2009. The original request was for the 0.5 mg dose because it presented the most benefits over potential risks compared to the 1.25 mg dosage. It was cleared by the FDA in 2010 and is now prescribed under the name Fingolimod.
FTY 720 MS proved to provide very substantial improvements over the standard medications that were administered by injection or infusion. Most of the patients involved in the trials sustained benefits from relapsing multiple sclerosis symptoms over two years, with some patients involved over 6 years. Patients had shown up to 60% fewer relapses compared to those receiving placebos. There were 52% lesser relapses when compared to interferon beta-1a (Avonex®) which was given by weekly intra muscular injections.
FTY 720 multiple sclerosis showed that there were increased improvements in stopping the progression of the disease. Maybe even more statistically significant were the magnetic resonance imaging (MRI) showing less lesion activity and reduced loss of brain volume.
For the patients and their caregivers taking a pill daily by mouth has proven to be much more convenient than facing IV or IM injections. It has been found patients are more likely to begin and stay on beneficial treatment regimes because of the trials run on FTY 720 MS.
Symptoms Addressed by FTY 720 MS and How It Works
There are basically two stages for those afflicted by MS. Firstly, they are likely to experience periods where they will have difficulty with movement or balance, have muscle spasms, and perhaps experience mental confusion. In the early stages, most patients will then have periods with no symptoms causing alarm. As the disease progresses, the times where they return to symptom-free periods becomes less frequent. The trials run with FTY 720 multiple sclerosis showed marked improvement for the patients in both reducing the flair ups and hindering the progression.
To explain in simplistic terms how it works, it is necessary to understand that T-cells are a type of white blood cell and part of a healthy immune system. In MS patients, it is believed these inflammatory lymphocytes end up attacking the fatty substance (myelin) that surrounds the nerve fibers in the central nervous system (CNS). The signals transmitted from the brain to the muscles then experience poor transmissions and the resulting symptoms. FTY 720 multiple sclerosis works to keep these cells ‘bottled up’ in the lymph nodes rather than being released into the body.
As far as side effects, the greatest risk may be in receiving the first dose. It is suggested it be taken under the supervision of a doctor for a period of six hours or so because of a decrease in the heart rate (bradycardia). Eye exams may be called for because macular edema may develop and liver enzymes may rise after 6 months of use. Otherwise, the most common complaints were headaches and some nausea, fatigue, and a higher risk of flu or respiratory ailments because of having a compromised immune system.
