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Acorda Therapeutics begins Phase 3 trials of Fampridine-SR for chronic spinal cord injury

Hawthorne, NY June 28, 2002 Acorda Therapeutics announced today that it has begun two Phase 3 clinical studies of its lead product, Fampridine-SR, in chronic spinal cord injury. The trials will evaluate the safety and efficacy of Fampridine-SR in the treatment of moderate-to-severe spasticity associated with chronic SCI. Spasticity, which affects up to 75% of people with chronic SCI, manifests itself as involuntary stiffness or contraction of muscles.

The studies will enroll a total of 360 patients at more than 70 of the leading spinal cord injury (SCI) clinical centers in the United States and Canada. Individuals who are interested in finding out about participating in these studies may call 866-206-2322, toll-free, weekdays from 9:00 a.m. (EDT) to 7:00p.m. (EDT)

"There is significant demand for new treatment options in chronic spinal cord injury, especially spasticity. Spasticity is a serious complication of SCI that frequently interferes with movement and daily activities, and can cause severe pain or injury," said Ron Cohen, MD, Acorda's President and Chief Executive Officer.

Fampridine ("4-aminopyridine", "4-AP") enhances conduction in damaged nerves, and is the first compound shown to restore some neurological function to people with SCI. Fampridine-SR is an oral, sustained-release formulation of fampridine, designed for twice-daily dosing. The drug restores nerve conduction by blocking exposed potassium channels in demyelinated nerve processes, or axons. Fampridine-SR is also in Phase 2 clinical trials to evaluate safety and efficacy in the treatment of symptoms associated with multiple sclerosis (MS).

In previous SCI clinical trials, administration of Fampridine-SR has been shown to reduce spasticity, and to improve sexual function and bowel and bladder control. The most common side effects observed with Fampridine-SR treatment have been pain, paresthesia, insomnia, dizziness, constipation, and nausea. At clin
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