|
A clinical trial is a research study in human volunteers designed to answer specific questions about the safety and/or efficacy of an experimental drug. Carefully conducted clinical trials are the safest and most effective way to find new treatments that improve people’s health.
For more information about clinical trials, you may refer to the NIH’s overview of the clinical process, available at www.clinicaltrials.gov.
Acorda’s clinical trials are designed to evaluate the safety and efficacy of potential treatments in order to bring new therapies to these markets, in which there are substantial unmet medical needs.
Acorda currently has one product candidate in clinical
development:
In June 2008, Acorda announced positive results from its second positive Phase 3 clinical trial of Fampridine-SR on walking ability in people with MS.
On May 6, 2009 Acorda announced that the U.S. Food and Drug Administration (FDA) accepted the Fampridine-SR New Drug Application (NDA) for filing, assigning Priority Review and a Prescription Drug User Fee Act (PDUFA) date of October 22, 2009. The PDUFA date is the target date for the FDA to complete its review of the Fampridine-SR NDA.
|