Oral MS drug research results published

21 January 2010

Research published online today in the New England Journal of Medicine (NEJM) suggests the new oral drug fingolimod may be more effective than current disease modifying drugs for MS.

The NEJM report covers two trials of fingolimod. TRANSFORMS was a one-year, randomised, double-blind, study comparing two doses of fingolimod to interferon beta-1a (Avonex).

The results showed a 52% reduction in the relapse rate for people on the lower dose of FTY720 and a 38% reduction with the higher dose compared to that seen in people taking interferon beta-1a. Similarly, 80% of people taking the lower dose of fingolimod and 83% on the higher dose didn't have a relapse during the year long study compared to 69% of those on interferon beta-1a.

Data from the two-year FREEDOMS study also showed that people on fingolimod experienced fewer relapses. This study compared two doses of fingolimod to a placebo and showed that the relapse rate was reduced by 60% for people on the lower dose and 54% for the higher dose. Disability progression, as measured by Expanded Disability Status Scale (EDSS), was reduced by 30% and 32% respectively for people taking fingolimod.

Side effects observed during FREEDOMS included reversible liver symptoms and mild elevation in blood pressure.

Fingolimod was submitted to the EMEA, the drug licensing body in Europe, at the end of 2009. Another oral drug, cladribine, was submitted for a license in Europe in July 2009.

Pam Macfarlane, Chief Executive of the MS Trust said, "We welcome the positive results of the study and the possibility that people with relapsing remitting MS may soon benefit from a wider range of treatments."

Cohen J, et al.
Oral fingolimod vs intramuscular interferon in relapsing multiple sclerosis.
New England Journal of Medicine 2010. [epub ahead of print 20 January 2010]

Kappos L, et al.
Placebo-controlled study of oral fingolimod in relapsing multiple sclerosis.
New England Journal of Medicine 2010. [epub ahead of print 20 January 2010]