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Earlier this year, the U.S. Food and Drug Administration (FDA) informed Medivation that this study can be used as one of the pivotal studies required to support the approval of Dimebon to treat mild-to-moderate Alzheimer's disease, as long as a significant proportion of the sites in the confirmatory Phase 3 trial are located in the United States. The Company recently began a confirmatory pivotal Phase 3 trial of Dimebon in Alzheimer's disease known as the CONNECTION study. Patients and caregivers can learn more about the study by visiting http://www.connectionstudy.com or by calling 1-877-888-6386.
About the Open-Label Extension
All patients who completed 12-months of dosing in the first pivotal trial were eligible to enroll in an open-label extension. All participants in the open-label extension received Dimebon, including patients who had previously received placebo during the prior 12 months of the trial. Because there was no placebo-control in the open-label extension, direct comparisons versus placebo cannot be made.
About Dimebon
Dimebon is an orally available small molecule that has been shown to inhibit brain cell death in preclinical models relevant to Alzheimer's and Huntington's diseases, making it a potential treatment for these and other neurodegenerative diseases. Preclinical data generated to date suggest that Dimebon operates through a novel mitochondrial mechanism of action.
On July 7, 2008, Medivation announced positive safety and efficacy
results from its Phase 2 trial of Dimebon for the treatment of Huntington's
disease, which was conducted in collaboration with the Huntington S
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| SOURCE Medivation, Inc. Copyright©2008 PR Newswire. All rights reserved |