Acorda Therapeutics(R) Initiates Phase 3 Clinical Trial of Fampridine-SR in Multiple Sclerosis


HAWTHORNE, N.Y.--(BUSINESS WIRE)--June 30, 2005--Acorda Therapeutics announced today that it has initiated a pivotal, Phase 3 clinical trial of Fampridine-SR in multiple sclerosis (MS). The study, which is based on a Special Protocol Assessment (SPA) issued by the Food and Drug Administration (FDA), will evaluate the safety and efficacy of Fampridine-SR in improving walking ability in people with MS.

The primary outcome measure for the study will be an improvement in walking ability; secondary outcomes will include measurements of leg strength and muscle spasticity. The studies will enroll a total of 240 patients at approximately 30 of the leading MS clinical centers in the United States and Canada. Individuals who are interested in learning about study enrollment may call 877-716-2518, toll-free, weekdays from 10:00am to 4:00pm (EST).

"Walking disability is one of the most important areas of unmet medical need in this population," said Andrew Goodman, M.D., Director of the MS Center at the University of Rochester Medical School and chairman of Acorda's MS advisory group. "Today's MS therapies act to prevent relapses and slow the progression of the disease but do not address the considerable loss of function experienced by these patients. A drug that could improve walking ability would be a significant and complementary addition to the current array of available therapies." According to the NARCOMS (North American Research Committee on Multiple Sclerosis) patient registry, approximately 80 percent of people with MS experience some degree of walking impairment. Additionally, mobility issues tend to worsen over time and seem to be independent of the type of MS diagnosed.

Ron Cohen, M.D., President and CEO of Acorda Therapeutics, said, "Acorda's mission is to develop therapies that improve neurological function in people with MS, SCI and related neurological disorders. We are delighted to have launched this pivotal trial, which is a key milestone in the fulfillment of that mission."

About Multiple Sclerosis