Experimental Pill for Multiple Sclerosis Sho... (milar safety concerns may arise with thi...)

Experimental Pill for Multiple Sclerosis Shows Promise

Date:4/16/2012

milar safety concerns may arise with this drug, Birnbaum said.

"In addition, the drug induces a lymphopenia [low white blood cell count], indicating it too is an immune suppressant. Immune suppression has its own dangers, as noted with fingolimod, where two patients died of liver infections, and there was an increased risk of skin cancer," Birnbaum said.

More study is needed to assess the long-term effectiveness and safety of ONO-4641, he said.

"At first glance, the drug appears to reduce central nervous system inflammation, but data on reducing [MS] disease progression and long-term safety will be needed to assess the final value of this drug," Birnbaum said.

For the trial, investigators randomly assigned 407 people aged 18 to 55 with relapsing-remitting MS to one of three daily doses of the drug or placebo. Patients underwent brain scans once every month between weeks 10 and 26 of treatment.

After 26 weeks, Vollmer's group found that compared to those taking a placebo, patients on the low dose of ONO-4641 experienced an average 82 percent reduction in what experts call "MS-enhancing brain lesions."

For those receiving the middle dose the reduction was 92 percent and for those on the high dose, 77 percent, they found.

Adverse events were related to the dose of the drug patients received and included cardiovascular events such as a slower heartbeat, blood pressure changes or other heart problems.

Other side effects included liver-enzyme elevations. In addition, lymphopenia occurred in 4 percent of people receiving the high dose of ONO-4641 and in 1 percent of those receiving the middle dose, the researchers note.

The study was supported by the drug's maker, Ono Pharmaceutical Co., Ltd.

Another expert, Nicholas LaRocca, vice president for health care delivery and policy research at the National MS Society, said that "MS is a complex disease that affects each person differently and so it is import
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