Fingolimod is the first oral disease-modifying therapy approved for the treatment of relapsing MS. Its clinical efficacy was investigated in three phase 3 clinical trials worldwide – TRANSFORMS, FREEDOMS, and FREEDOMS II.
A phase 3 trial is when the efficacy of a drug is compared to a placebo (a dummy drug) and is tested on hundreds of patients worldwide. When a clinical trial shows that a drug is really effective in treating a disease, an extension of the same trial might be proposed to further investigate the drug’s long-term efficacy, safety, and tolerability.
Neurology magazine reports the results of an extension of the FREEDOMS trial on fingolimod involving 920 patients. During the extension phase, two doses of fingolimod were tested once a day.
Overall, the extension of the FREEDOMS study shows that benefits were sustained and that fingolimod is effective in reducing relapses and brain volume loss. The study also confirms there is no significant difference in efficacy between the two doses tested. Finally, no new safety or tolerability issues were observed.