Acadia Pharmaceuticals oral treatment has been denied by U.S. Food and Drug Administration for extended use. The extension would have granted access for the drug to be used for treating Alzheimer's symptoms.
The extension was denied due to insufficient results after a drug trial, and Acadia was instructed to conduct another trial before the FDA could approve.
“Acadia Pharmaceuticals oral treatment has been denied by U.S. Food and Drug Administration for extended use“
The FDA’s outcome follows a majority (9-3) of external opinions against the extension as there was a lack of sufficient evidence that the drug aided patients with severe Alzheimer’s symptoms.
Steve Davis, leading executive of Acadia commented, "We are disappointed with this outcome. The treatment of Alzheimer's disease psychosis continues to be an area of high unmet need, for which there is no approved therapy,"
This is the second time the FDA has declined the extension of the treatment. In spring of 2021, the drug was denied for use on dementia patients due to lack of adequate results from Acadia's clinical study.
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