Another oral drug for relapsing multiple sclerosis — teriflunomide — looks to be on a smooth path to approval,

In a 1,088-patient trial called TEMSO, teriflunomide reduced annualized relapse rates by about 30% relative to placebo, according to Paul O’Connor, MD, of the University of Toronto, and colleagues in the Oct. 6 issue of the New England Journal of Medicine.

Disability progression in the two-year study was also less frequent in patients receiving the once-daily drug: 21.7% of patients taking a 7-mg/day dose and 20.2% of those taking 14 mg/day showed progression, compared with 27.3% of the placebo group, the researchers indicated.

Much of the TEMSO data had been presented at meetings, including those of the European Committee for Treatment and Research in Multiple Sclerosis in 2010 and the American Academy of Neurology and Consortium of Multiple Sclerosis Centers earlier this year.

Teriflunomide is the active metabolite of leflunomide, a standard rheumatoid arthritis drug. Its specific mechanism of action is to inhibit pyrimidine synthesis, which in turn reduces proliferation of certain immune cells.

TEMSO — one of five phase III trials of teriflunomide in MS and the first to be completed — enrolled patients in 21 countries with relapsing forms of the disease scoring no more than 5.5 on the Expanded Disability Status Scale, indicating low to moderate disability.

Participants also had at least two relapses during the previous two years or one relapse in the past year, but none in the 60 days prior to randomization.

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