ACADIA Pharmaceuticals Inc. (ACAD) announced that the 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, or NDA, for the treatment of Parkinson's disease psychosis, or PDP. ACADIA will no longer conduct the Phase III -021 study that was planned as a confirmatory trial. ACADIA believes FDA decision will reduce substantially both the time and cost of the company's PDP development program.
ACADIA is currently focused on completing the remaining elements of its pimavanserin PDP development program that are needed for submission of an NDA. ACADIA is currently targeting an NDA submission near the end of 2014.
by RTT Staff Writer
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