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Acadia Pharmaceuticals Inc Announces Expedited Path To NDA Filing For Pimavanserin Following Meeting With FDA


Thursday, 11 Apr 2013 07:00am EDT 

Acadia Pharmaceuticals Inc announced that the U.S. Food and Drug Administration (FDA) has agreed that the data from the pivotal Phase III -020 study, together with supportive data from other studies with pimavanserin, are sufficient to support the filing of a New Drug Application (NDA) for the treatment of Parkinson's disease psychosis (PDP). As a result, ACADIA will no longer conduct the Phase III -021 study that was planned as a confirmatory trial and was scheduled to be initiated later this month. ACADIA is currently focused on completing the remaining elements of pimavanserin PDP development program that are needed for submission of an NDA. These include customary supportive studies, such as drug-drug interaction studies, and CMC development, such as stability testing of registration batches. Subject to changes that could result from future interactions with the FDA or other developments, ACADIA is currently targeting an NDA submission near the end of 2014. 

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9 Jul 2014