Hawthorne-based Acorda reaches FDA agreement
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- May
- 22
Acorda Therapeutics Inc., a Hawthorne-based biotechnology company, has reached an agreement with the U.S. Food and Drug Administration on a new Phase 3 clinical trial for its treatment for patients with Multiple Sclerosis.
The FDA has agreed to a Special Protocol Assessment for Acorda, which means the ageny will provide evaluation and guidance on the clinical trial protocols for the Phase 3 study.
The goal of the study is to show that people treated with Fampridine-SR are significantly more likely to have consistent improvement in their walking ability.
If the trial is successful, the FDA agreed that the new trial, along with the company’s first Phase 3 trail, will be enough to support a new drug application for Fampridine-SR.
Ron Cohen, founder, president and chief executive of Acorda, said there are no therapies approved for improving mobility in people with MS.
The new trial, which will measure patients’ walking speed, will be conducted at about 35 MS centers in the United States and Canada. About 200 people are expected to be enrolled.
This entry was posted
on Tuesday, May 22nd, 2007 at 5:43 pm by Julie Moran Alterio.
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