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12:00 AM
Apr 19, 2004
 |  BioCentury  |  Product Development

Acorda's hopes in MS

Fampridine has been used for spasticity in multiple sclerosis for more than a decade by patients who get it compounded by pharmacists. But clinical proof that it works will have to wait, as Acorda Therapeutics Inc.'s Fampridine-SR sustained release version missed the primary endpoint in a Phase II trial in MS last week, as well as in two Phase III trials to treat chronic spinal cord injury (SCI). But the company plans to have another go at it.

In the SCI trials reported last week, the neuronal potassium channel blocker did not significantly reduce spasticity, as measured by the Ashworth score, or significantly improve patients' Subject Global Impression rating. Acorda is analyzing the secondary endpoints of improvement in bowel, bladder or sexual function, before detailing a path forward for Fampridine-SR in the indication.

In the MS trial, Fampridine-SR showed a trend in improvement in walking speed, the primary endpoint. There also was a significant improvement in leg muscle strength, a secondary endpoint, giving the company comfort that it could be first to demonstrate functional improvement in this disease.

In both cases, Acorda continues to face a lack of well-defined endpoints. But given the severity of the problems faced by patients, it is conceivable that success on any one of a series of other endpoints could be enough for approval.

Spinal cord injury

According to CEO Ron Cohen, Fampridine-SR is thought to improve neuronal conductivity by blocking the potassium channels on axons that have become...

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