After meeting with the U.S. Food and Drug Administration, Acadia intends to file an approval application for pimavanserin based on data from a successful phase III study completed last year, plus other supportive data.
The company will no longer conduct a confirmatory phase III study that was planned to begin later this month.
The FDA approval filing for pimavanserin as a treatment for Parkinson's psychosis is expected near the end of 2014. FDA will subject the pimavanserin filing to a standard review, which suggests a review cycle of 12 months. If approved, pimavanserin could reach the U.S. market in late 2015.Acadia shares are up 25% to $9.94 in pre-market trading. -- Reported by Adam Feuerstein in Boston. Follow Adam Feuerstein on Twitter.
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