Oral treatment reduces multiple sclerosis flare-ups

More than two thirds of multiple sclerosis (MS) patients receiving the investigational oral immunomodulator FTY720 (fingolimod, Novartis) remained relapse-free after three years of treatment, according to Phase II results reported at the 60th Annual Meeting of the American Academy of Neurology (AAN), held recently in Chicago.

"The findings are impressive given that all current treatments for MS must be injected or infused," Giancarlo Comi, M.D., professor of neurology at Vita-Salute San Raffaele University in Milan, Italy, observed. Also, first-line treatments decrease relapses by only about 30%, he said.

Comi described results of an extension study in 173 patients with relapsing MS who have thus far completed three years of FTY720 treatment following a six-month study in which they had been assigned to the experimental drug or placebo.

Magnetic resonance imaging (MRI) showed that the inflammatory activity associated with MS remained low. Overall, 89% of patients had no disease activity and 75% had no new or newly enlarged lesions.

The most common treatment-related side effects were headache, fatigue, flu, and cold symptoms. There were also seven cases of skin cancer. "An effective oral treatment would be a true breakthrough for MS patients, and it appears we may be close to that goal," Comi said. FTY720 is an oral sphingosine 1-phosphate (S1P) receptor modulator.

Other studies presented at AAN covered the following:

Parkinson's disease

Levodopa/carbidopa/entacapone (LCE) (Stalevo, Orion) improves symptoms in patients with early Parkinson's disease (PD) more than levodopa/carbidopa (LC, Sinemet, Bristol-Myers Squibb), the treatment standard, according to the results of a Phase III trial.

Robert Hauser, M.D., professor of neurology at the University of South Florida in Tampa, reported data in 423 patients who had been randomized to fixed-dose LCE 100/25/200 mg or LC 100/25 mg tid for 39 weeks.

Levodopa/carbidopa/entacapone demonstrated a significant improvement over levodopa/carbidopa in the primary outcome measure, which was the change in combined Unified PD Rating Scale (UPDRS) Part II activities of daily living (ADL) and Part III motor scores. Significantly, the improvement with the triple-drug combination occurred without an increase in motor complications, Hauser noted. Levodopa/carbidopa/entacapone is indicated for patients with advanced PD experiencing wearing-off.

Diabetic neuropathic pain

The investigational agent lacosamide (UCB Pharma) is effective and well tolerated when used to treat diabetic neuropathic pain, a recent analysis shows.

Aziz Shaibani, M.D., clinical assistant professor of medicine at Baylor College of Medicine in Houston, reported pooled efficacy and safety data in patients treated with lacosamide, 400 mg/d, versus placebo, in three, 12-week Phase III trials.

Results showed a mean 2.5 point decrease in pain on the 11-point Likert scale at the end of treatment in the 285 lacosamide-treated patients versus a 1.8 point decrease in the 88 placebo-treated patients. About a third of the lacosamide cohort reported 50% or more pain reduction. Most patients had used prior medications for diabetic neuropathic pain, and most of them had responded poorly to such treatments.

Treatment-related side effects observed more often with lacosamide included dizziness, fatigue, nausea, and tremor. Lacosamide did not lengthen the QT interval or cause significant leg or foot edema or sleepiness, all of which are frequently reported with common treatments for diabetic neuropathic pain.

THE AUTHOR is a medical writer based in Paris.