MS Pill Shows Promise In Reducing Relapses

Posted: Published on September 21st, 2012

This post was added by Dr Simmons

Featured Article Academic Journal Main Category: Multiple Sclerosis Also Included In: Clinical Trials / Drug Trials Article Date: 20 Sep 2012 - 7:00 PDT

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The studies report the results of two phase 3 clinical trials, DEFINE and CONFIRM, evaluating oral BG-12 (dimethyl fumarate) for the treatment of MS. They are published in the 19 September online issue of the New England Journal of Medicine, NEJM.

The dose used in the trials was 240 mg of dimethyl fumarate, administered twice daily, or three times a day.

The results show that at this dose, compared to placebo, the drug resulted in significant and clinically meaningful reductions in MS relapses and brain lesions in patients with relapsing-remitting MS, as well as some benefit in slowing disease progression.

About 85% of people with MS have the relapsing-remitting form (RRMS), which means there are times when the disease flares up and is very active, and at other times it quietens down or remits. During remission periods, the symptoms can almost disappear, and the disease barely progresses.

"The publication of both dimethyl fumarate pivotal studies in NEJM is another achievement for this important investigational therapy," says Dawson in a press statement released on Wednesday.

"The data from its clinical development program consistently indicate that dimethyl fumarate may provide tangible benefits and address existing treatment needs of people living with MS. We are working closely with regulatory authorities across the globe with the aim of making the review of dimethyl fumarate as quick as possible," she adds.

The drug is currently being reviewed by regulatory authorities in the United States, European Union, Australia, Canada and Switzerland.

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MS Pill Shows Promise In Reducing Relapses

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